British Association for Sexual Health and HIV national guideline for the management of infection with Mycoplasma genitalium (2018)

Abstract

This is the first British Association for Sexual Health and HIV (BASHH) guideline for the diagnosis and management of Mycoplasma genitalium in people aged 16 years and older. The guideline is primarily aimed at level 3 sexually transmitted infection (STI) management services within the UK, although it could also serve as a reference guide for STI services at other levels.

Keywords

Non-gonococcal urethritis bacterial disease urethritis (bacterial)diagnosis epidemiology treatment

Introduction

Whilst the guideline sets out recommendations for best practice according to current evidence, it is acknowledged that not all clinics will have access to M. genitalium testing at the time of guideline publication. The objective of this guideline is therefore also to assist clinics and laboratories in making the case for funding towards M. genitalium testing by underlining the importance of testing in relevant populations.

Search strategy

The writing group determined PICO (Patient, Intervention, Comparison, Outcome) questions which formed the basis for the literature search. The questions are listed in Appendix 1.

A search was conducted using Medline, Embase, the Cochrane library and NHS Evidence. The search heading was kept broad (‘genitalium’) to include all the guideline questions. Only publications in the English language were considered. Age, country and study design limits were included in the PICO criteria, except that studies from Japan were considered for questions 8, 9 and 10 because it was felt that evidence in these studies, particularly with respect to resistance and treatment issues, would contribute significantly to and inform the guideline (see Appendix 1). ‘Grey literature’ included conference abstracts from IUSTI, BASHH, BHIVA, ICAAC, ASHM and ECCMID scientific meetings in the last three years. The writing group used a modified GRADE system for assessing evidence and formulating recommendations.

Equality impact assessment

An assessment of the guideline recommendations was made according to the principles of the NICE equality policy (Appendix 2).

Stakeholder involvement, piloting and feedback

The draft guideline recommendations were presented at the joint British HIV Association (BHIVA) and BASHH annual conference in 2018. The draft guideline was appraised by the CEG using the AGREE instrument, posted on the BASHH website for a consultation period of two months, and piloted in a sample of clinics. In response to the consultation, suitable amendments were made to the guideline and the final draft was submitted to the CEG. The patient information leaflet (PIL) was reviewed by the CEG, BASHH patient and public panel, and also piloted in a sample of clinics and comments were reviewed and incorporated where appropriate.

The writing group consisted of genitourinary medicine physicians with experience in managing M. genitalium (SS, MR, NPS, PH), a consultant microbiologist (HF), a pharmacist (NN), a sexual health advisor (AP) and two patient representatives (DB, CP).

The guideline will be updated every five years according to the BASHH CEG guideline framework. This interval could be shorter should new data arise that could significantly impact recommendations.

Patient and public involvement

Two patient representatives attended a writing group meeting, contributed to the design and written content of the PIL and commented on the draft guidelines. The guideline was also reviewed by the BASHH Patient and Public Panel.

Summary of recommendations

Recommendation	Grading
Test for M. genitalium infection in all males with non-gonococcal urethritis	1B
Test for M. genitalium infection in all individuals with signs and symptoms suggestive of pelvic inflammatory disease (PID)	1B
Test current sexual partners of persons infected with M. genitalium	1D
First void urine is the specimen of choice in males	1C
Vaginal swabs (clinician- or self-taken) are the specimen of choice in females	1C
All M. genitalium-positive specimens should be tested for macrolide resistance- mediating mutations	1B
Treatment regimens for uncomplicated infection:
Doxycycline 100 mg two times daily for 7 days followed by azithromycin 1 g orally as a single dose then 500 mg orally once daily for 2 days	1D
Moxifloxacin 400 mg orally once daily for 10 days	1B
Treatment regimens for complicated infection:
Moxifloxacin 400 mg orally once daily for 14 days	1D
Alternative treatment regimens:
Doxycycline 100 mg two times daily for 7 days followed by pristinamycin 1 g orally four times daily for 10 days	2C
Pristinamycin 1 g orally four times daily for 10 days	2C
Doxycycline 100 mg orally twice daily for 14 days	2C
Minocycline 100 mg orally twice daily for 14 days	2D
All patients should attend for a test-of-cure five weeks (and no sooner than three weeks) after the start of treatment to ensure microbiological cure	1D

Microbiology

M. genitalium was first isolated in 1981, having been cultured from urethral specimens of two men presenting with non-gonococcal urethritis (NGU).¹ M. genitalium belongs to the Mollicutes class,² and with a genome of only 580 kilobases in size, is the smallest known self-replicating bacterium. It lacks a cell wall, and hence is not visible by Gram stain. The organism is fastidious and typically requires weeks or months to culture.

M. genitalium has been detected from genito-urinary, rectal and respiratory tract specimens, but carriage in the throat seems to be rare.³ Although it was initially thought that disease appeared to be limited to the genito-urinary tract, there is some evidence it could potentially cause proctitis.^3–5 The specialised tip-like structure of M. genitalium enables it to adhere to and invade epithelial cells.³ The organism is able to evade the adaptive immune system possibly through both its ability to establish intra-cellular infection and by antigenic and phase variation of its surface-exposed proteins, and infection may persist for months or years.^3,6,7 Although the diseases associated with M. genitalium infection are thought largely to be as a result of the host immune response rather than organism-specific features, it has been demonstrated in human fallopian tube organ culture that infection can be directly toxic to cells resulting in cilial damage.^4,7,8

Epidemiology

Prevalence in general population and risk factors for infection

Prevalence estimates for M. genitalium infection in men and women in the general population range from 1 to 2%, being slightly higher in women.^9–11 Similar to C. trachomatis, risk factors for M. genitalium infection include younger age, non-white ethnicity, smoking, and increasing number of sexual partners.^9–11 However, the prevalence of M. genitalium infection appears to peak later than that for C. trachomatis, particularly in men, and to remain higher in older age groups.^11–13 Amongst STI clinic attendees, prevalence ranges are higher, from 4 to 38%.^14–16

Sexual transmission

In addition to the sexual behavioural risk factors above, sexual transmission is supported by the observation that sexual partners of individuals diagnosed with M. genitalium are more likely to be infected than controls.^17–19 Molecular epidemiological studies also support a sexual transmission model: in DNA-typing studies, sexual partners who were concurrently infected with M. genitalium frequently carry genetically identical strains.^20–22

Transmission is primarily by genital–genital contact, but M. genitalium has also been detected in the ano-rectal compartment^5,23 and transmission by penile–anal contact has been established.²⁴ As carriage in the oro-pharynx is uncommon, the relative contribution of oral sex is likely to be very small.^25–27 The risk of transmission per coital act has yet to be determined but is likely to be less than that for chlamydia.²⁷

Co-infection with other STIs

M. genitalium is associated with the detection of other bacterial STIs, C. trachomatis being the most frequently isolated co-organism.^28–31 An association between M. genitalium and HIV transmission and acquisition is biologically plausible and supported by some studies in sub-Saharan Africa.^6,16,32

Clinical associations

Non-gonococcal urethritis

M. genitalium infection is unequivocally and strongly associated with NGU. Typically, the prevalence of M. genitalium in men with NGU is 15–25% and in male patients with non-chlamydial nongonococcal urethritis (NCNGU) is 10–35%,³ as compared to 1–2% in the general population.^11,33 In one meta-analysis of 19 observational studies examining M. genitalium infection using molecular techniques, 436/2069 patients with NGU (21.1%) were positive for M. genitalium versus 121/1810 controls (6.7%), yielding a pooled odds ratio of 3.8 (95% CI 3.0–4.9).¹³ Further systematic reviews have demonstrated a similar association, and demonstrated a yet stronger strength of association with NCNGU.³ M. genitalium is also associated with persistent and recurrent urethritis, where up to 40% of affected men may have M. genitalium detected.³⁴ A recent meta-analysis demonstrated an odds ratio of 26 for M. genitalium detection in men with persistent urethritis.³⁵

M. genitalium in the female reproductive tract

Several studies support an association of M. genitalium infection in cisgender women with post coital bleeding and cervicitis, endometritis and pelvic inflammatory disease (PID).^{11,18,36–39}

A recent meta-analysis has demonstrated significant associations between M. genitalium and cervicitis (pooled OR 1.66) and PID (pooled OR 2.14), in addition to pre-term birth and spontaneous abortion (pooled ORs 1.89 and 1.82, respectively).³⁹ M. genitalium is linked aetiologically to PID and accounts for 10–13% of cases of PID.^41,42 It has been shown to ascend from the lower to upper female genital tract,³ has been detected frequently from endometrial biopsies in women with PID⁴³ and can cause epithelial cilial damage in human fallopian tube culture. However, an association with tubal factor infertility has not yet been demonstrated and conducting studies to determine this will be difficult.^3,8,44

Asymptomatic infection

The evidence suggests that the majority of people infected with M. genitalium in the genital tract do not develop disease.^27,45,46 Current treatments are imperfect and associated with development of antimicrobial resistance.^47,48 There is no evidence that screening asymptomatic individuals will be of benefit, and indeed is likely to do harm at a population level.⁴⁹

Current asymptomatic partners (including non-regular partners where there is likely to be further sexual contact and risk of reinfection) of individuals with disease caused by M. genitalium infection should be tested and/or offered epidemiological treatment (using the same antimicrobial regimen as used in the index patient). This is to reduce the risk of re-infection in the index case.

Clinical features

Signs and symptoms in males³

None – the majority are asymptomatic²⁷

Urethral discharge

Dysuria

Penile irritation

Urethral discomfort

Urethritis (acute, persistent, recurrent)

Balanoposthitis (in one study)⁵⁰

Complications in males

Sexually acquired reactive arthritis

Epididymo-orchitis

The clinical presentation of M. genitalium urethritis is similar to other causes and thus clinical features of acute symptomatic NGU cannot be used to determine the infective aetiology.^{17,27,51–54} Although the proportion of infected men that develop symptoms is unknown, this is likely to be <10%.²⁷

Urethral discharge may be present spontaneously or upon expression, and urethritis is confirmed by demonstrating five or more polymorphonuclear leucocytes (PMNLs) per high power (×1000) microscopic field (averaged over five fields with the greatest concentration of PMNLs) on a smear obtained from the anterior urethra.⁵⁵

It is possible that sexually acquired reactive arthritis may occur as a result of M. genitalium infection.^3,27,56 An association with epididymo-orchitis is possible, but current data are lacking to support an association with prostatitis.³ M. genitalium has been demonstrated at high prevalence in rectal samples from men who have sex with men (MSM) (particularly HIV-positive MSM), and one study showed that men with symptoms of proctitis had higher bacterial load of M. genitalium than those without rectal symptoms, suggesting a potential association.^5,23 This warrants further investigation with larger studies.

Signs and symptoms in females

None – the majority are asymptomatic^18,38

Dysuria

Post-coital bleeding

Painful inter-menstrual bleeding

Cervicitis

Lower abdominal pain (see Complications: PID)

Complications in females

Pelvic inflammatory disease

Tubal factor infertility (uncertain association)

Sexually acquired reactive arthritis

Pre-term delivery

Individuals with cervicitis due to M. genitalium frequently have no symptoms at all. If present, symptoms are nonspecific, with the most common symptom being post-coital bleeding.⁵⁷ Although the proportion of infected women who develop symptoms is unknown this is likely to be <5%.^45,46

Examination is frequently normal, but on speculum examination the presence of mucopurulent cervical discharge, cervical friability and elevated numbers of PMNLs on cervical sample Gram staining are suggestive of infection.^18,36,38,58

Clinical signs and symptoms of M. genitalium-associated PID are similar to, and indistinguishable from, PID due to C. trachomatis.

Recommendations for testing

Based on symptoms

We recommend testing for M. genitalium infection in people with non-gonococcal urethritis (1B)

We recommend testing for M. genitalium infection in people with signs and symptoms suggestive of pelvic inflammatory disease (1B)

Consider testing for M. genitalium infection in people with signs or symptoms of mucopurulent cervicitis, particularly post-coital bleeding (2B)

Consider testing for M. genitalium infection in people with epididymo-orchitis (2D)

Consider testing for M. genitalium infection in people with sexually-acquired proctitis (2D)

Based on risk factors

We recommend testing current sexual partners of persons infected with M. genitalium (1D)

There are currently insufficient data to recommend routine screening for M. genitalium infection in asymptomatic individuals. Asymptomatic individuals with confirmed chlamydia and/or gonorrhoea infection should not be routinely tested for M. genitalium.

Whilst the recommendation to test all men with NGU is clear, it is acknowledged that, at the time of writing, access to M. genitalium testing is limited and sending all specimens to the Public Health England (PHE) Reference laboratory for M. genitalium detection and/or determination of resistance status may not be cost viable. Given that some men clear M. genitalium with doxycycline treatment alone (for NGU), an alternative strategy would be to test men who remain symptomatic following doxycycline and use AMR-guided therapy to treat any positives. However this is not preferable because it would result in a longer patient journey and may miss infection in some individuals who become asymptomatic but who have not cleared infection.

Diagnosis

M. genitalium has fastidious nutritional requirements and is extremely slow growing therefore culture is not appropriate for diagnosis. Nucleic acid amplification tests (NAATs) that detect M. genitalium-specific DNA or RNA in clinical specimens are the only useful diagnostic method. Several CE-marked commercial tests are available, although none are currently FDA approved. Careful consideration of assay performance based on published data is essential, as the different NAATs are likely to have varying performance and lack extensive validation.⁵⁹ Local validation is required before the implementation of any test.

It is recommended that all M. genitalium-positive specimens should be tested for macrolide resistance-mediating mutations. Recently, commercial assays detecting macrolide resistance have become available. In the absence of local resistance testing, the PHE Reference laboratory offers a molecular macrolide and fluoroquinolone susceptibility genotyping assay for specimens positive for M. genitalium. Currently there are no commercial assays available in the UK which detect mutations associated with fluoroquinolone resistance although these are likely to be available in the near future.

Specimen collection

The published data for the optimal specimen type are generally from small studies using a variety of different NAATs with different sensitivities, and which lack thorough validation; therefore, the recommendations are based mainly on a practical approach to specimen collection.

Men

First void urine (FVU) is the most sensitive specimen type (sensitivity 98–100%).^13,59–61 FVU has been shown to be more sensitive than urethral swabs.^13,59,62

There are sparse and conflicting data for meatal swabs; in one study, self-taken penile meatal swabs compared with urethral swabs had a sensitivity of 79% for M. genitalium, whereas in the same study the sensitivity for detection of C. trachomatis was 98%.⁶³ Another study detected more infections using self-taken meatal swabs than FVU (15.3% vs. 12.6%).⁶⁴

Women

Most studies suggest that in women, vulvovaginal swabs are the most sensitive specimen, followed by endocervical swabs.^59,65–67 Using both vaginal and endocervical swabs increases the sensitivity further (sensitivity using a PCR assay: vaginal 85.7%, endocervical 74.3%, combined 95.7%). In one study, a quarter of infections would have been missed by only testing one specimen.⁶³ A recent study using a more sensitive assay⁵⁹ suggests that a vaginal swab alone is sufficient (sensitivity of vaginal swab 100%, endocervical swab 95.6%).

In the majority of published studies, FVU in cisgender women was found to be less sensitive than vaginal or endocervical swabs (FVU sensitivity 58–71%).^13,66,67 However a few small studies have found no significant difference in the sensitivity between specimen types,⁶⁰ or FVU to be superior to vaginal swabs.^62,68

Considerations for people following gender reassignment surgery

There is a paucity of data concerning M. genitalium infection in individuals following gender reassignment surgery. It is therefore difficult to recommend an optimal specimen type but this should be guided by sexual history and symptoms. For more detail, clinicians should refer to the forthcoming BASHH standards for trans and non-binary people document.

Recommendations

We recommend first void urine as the specimen of choice in cisgender men (1C)

We recommend vaginal swabs (clinician- or self-taken) as the specimen of choice in cisgender women (1C)

We recommend that, where possible, all M. genitalium-positive specimens should be tested for macrolide resistance-mediating mutations (1B)

Window period

There are no data on the incubation period for M. genitalium, or on the likely window period before a laboratory test becomes reliably positive. However, it is likely that sensitive tests will detect early infection.

Management

General advice

Patients should be given a detailed explanation of their condition with particular emphasis on the long-term implications for the health of themselves and their partner(s). This should be reinforced with clear and accurate written information. A patient information leaflet for M. genitalium can be found on the guidelines page of the BASHH website. This will be updated when new guidance is published or new information becomes available.

Patients should be advised to abstain from sexual intercourse until 14 days after the start of treatment, and until symptoms have resolved. Where azithromycin has been used this is especially important because of its long half-life, and is likely to reduce the risk of selecting/inducing macrolide resistance if the patient is re-exposed to M. genitalium. We recommend a test of cure (TOC) should be performed in all patients.

Treatment of uncomplicated urogenital infection (urethritis, cervicitis)

Eradication rates of M. genitalium following treatment with macrolides are decreasing globally and rates of resistance are 30–100%.⁶⁹ Macrolide resistance in the UK is estimated at around 40% although data are lacking.⁷⁰ Reference laboratory data show higher rates of resistance but are biased as isolates tend to come from patients who have previously failed treatment.⁷¹

Despite this M. genitalium still responds to azithromycin in the majority of cases. This has previously been given as 500 mg single dose followed by 250 mg once daily for four days, although the evidence that this regimen is less likely to select for macrolide resistance than 1 g as a single dose is conflicting.²⁷ More recently, data from Australia using a total of 2.5 g azithromycin over four days showed much lower rates of treatment failure in combination with resistance-guided management.⁷² Although never evaluated, using a 2 g dose over three days (1 g followed by 500 mg for two days) may improve microbiological cure rates and reduce the risk of macrolide resistance developing in M. genitalium, whilst being tolerable.⁵⁵

Knowledge of macrolide resistance status is important in determining whether azithromycin should be given but will depend on such testing being available. Even where an organism is known to be initially macrolide-sensitive, an azithromycin regimen should not be repeated following treatment failure because it is likely that resistance has developed on treatment.

Although doxycycline as monotherapy has poor efficacy and eradication rates are low at about 30–40%, there is evidence that prior treatment with doxycycline may improve treatment success when given with, or followed by an extended azithromycin regimen.^27,72 This is biologically plausible as doxycycline reduces the organism load and hence the risk of pre-existing macrolide mutations being present. However evidence for this approach is limited, and clinicians should collate and share evidence to inform the utility of this practice.

Moxifloxacin still has excellent efficacy in Europe^52,73 although resistance is increasing in Asia-Pacific where its use is greater.⁷⁴ Using moxifloxacin first line in all cases of M. genitalium is not recommended because future therapeutic options are limited. Regarding optimal duration of therapy, a recent meta-analysis reported no significant difference in seven- and ten-day regimens, although more treatment failures were seen in the seven-day regimens. Thus, ten days is preferred.⁷⁵

See Figure 1 for the suggested treatment pathway for men presenting with NGU who subsequently test positive for M. genitalium.

Figure 1.

Suggested treatment pathway for men presenting with non-gonococcal urethritis who subsequently test positive for M. genitalium. *Azithromycin 3 d should be started within two weeks of finishing doxycycline. MG: Mycoplasma genitalium; Doxycycline: doxycycline 100 mg bd for seven days; Azith romycin 3 d: azithromycin 1 g, then 500 mg od for two days; Moxifloxacin 10 d: moxifloxacin 400 mg od for ten days; MRAM: macrolide resistance-associated mutation; TOC: test of cure.

Recommended regimens (uncomplicated infections):

Doxycycline 100 mg bd for seven days followed by azithromycin 1 g orally as a single dose then 500 mg orally once daily for two days* where the organism is known to be macrolide-sensitive or where resistance status is unknown (1D).

Moxifloxacin 400 mg orally once daily for ten days if organism is known to be macrolide-resistant or where treatment with azithromycin has failed** (1B).

*Given that most individuals will have had doxycycline as first-line treatment for uncomplicated infection, a repeat course is unnecessary once the M. genitalium-positive result is known. Azithromycin should be given immediately after doxycycline, and ideally within two weeks of completing doxycycline. If this is not possible, the course of doxycycline should be repeated prior to giving azithromycin.

**Treatment failure is defined as persistent symptoms following treatment, or a positive test of cure taken five weeks post-treatment.

Treatment of complicated urogenital infection (PID, epididymo-orchitis)

There are few studies examining the efficacy of extended azithromycin regimens in the treatment of PID and epididymo-orchitis caused by M. genitalium. Data from a recent PID RCT showed high rates of macrolide resistance-mediating mutations in specimens positive for M. genitalium.⁴² Given the need for prompt and effective treatment in complex STI syndromes, patients with confirmed M. genitalium infection, or who have a partner who has tested positive for M. genitalium should be given moxifloxacin as a 14-day regimen.⁷⁵

Recommended regimens (complicated infection):

Moxifloxacin 400 mg orally once daily for 14 days (1D).

Partner notification

Only current partner(s) (including non-regular partners where there is likely to be further sexual contact) should be tested and treated if positive. This is to reduce the risk of re-infection to the index patient. Partners should be given the same antibiotic as the index patient unless there is available resistance information to suggest otherwise.

Alternative regimens

Very little evidence exists for the effectiveness of the following regimens but they may be considered:

Doxycycline 100 mg bd for seven days* then pristinamycin 1 g orally four times daily for ten days⁷⁶

Pristinamycin 1 g orally four times daily for 10 days⁷⁶

Doxycycline 100 mg orally twice daily for 14 days^77,78

Minocycline 100 mg orally twice daily for 14 days⁷⁹^–⁸¹

*Prior treatment with doxycycline will reduce M. genitalium load and has been demonstrated to be of benefit if administered prior to extended azithromycin and also pristinamycin treatment which is only 75% effective as mono-therapy.²⁷

Rectal infection

This should be managed in the same way as urogenital infection. For severe proctitis, a longer course of moxifloxacin (14 days) may be considered.

Sourcing of unlicensed products

Pristinamycin is not currently available in the UK and must be imported against a prescription. The cost of importing medicines can be high and availability is inconsistent. An MHRA register of licensed wholesalers who can import medicines without a UK Marketing Authorisation is available at: https://www.gov.uk/government/publications/human-and-vetinary-medicines-register-of-licensedwholesale-distribution-sites-december-2014. At the time of writing, pristinamycin was available from several wholesalers with a lead time of two to three weeks.

Pregnancy and breastfeeding

Pregnancy

Data on M. genitalium and its association with adverse pregnancy outcomes are limited; however, it has been associated with a small increased risk of preterm delivery and spontaneous abortion.^40,44,82,83

Azithromycin use during pregnancy is unlikely to increase the risk of birth defects or adverse pregnancy outcomes.^84–86 A three-day course of azithromycin can be used for uncomplicated M. genitalium infection detected in pregnancy. The use of moxifloxacin in pregnancy is contra-indicated. In women with likely macrolide resistance, or with upper genital tract infection in pregnancy, options are limited.^87–89 Although doxycycline is considered safe for use in the first trimester by the FDA, the BNF advises against its use in all trimesters. There are no data regarding the use of pristinamycin in pregnancy. An informed discussion should be with the pregnant woman around the risks associated with the use of these medicines in pregnancy and the risks of adverse outcomes associated with M. genitalium infection, and where possible treatment should be delayed until after pregnancy.

Breastfeeding

Very low levels of azithromycin are detected in breast milk, and systemic exposure in infants does not exceed that observed when azithromycin is administered for treatment, therefore risk is considered to be low.⁹⁰ Infants should be monitored for possible side effects due to effects on the gastrointestinal flora including diarrhoea and candidiasis. A large cohort study found a significantly increased risk of pyloric stenosis in breastfed infants with maternal use of macrolides between 0 and 13 days of delivery.⁹¹ Doxycycline is excreted into breast milk and is contraindicated in nursing mothers due to the risk of tooth discolouration and effects on bone growth. Use of moxifloxacin is contraindicated during breastfeeding. Pristinamycin is contraindicated during breastfeeding due to its side effect profile.⁹²

Adverse events

Azithromycin, doxycycline, moxifloxacin and pristinamycin can all cause gastro-intestinal problems including nausea but symptoms are most frequently reported with doxycycline and azithromycin doses over 1 g. Caution should be taken when prescribing azithromycin or moxifloxacin to patients already on medications which may prolong the QT interval. The European Medicines Agency committee has recommended that the use of fluoroquinolone antibiotics should be restricted following a review of their disabling and potentially long-lasting side effects.⁹³ Healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of side effects involving muscles, tendons, bones or the nervous system. The only absolute contra-indication to moxifloxacin is known hypersensitivity to this class of drugs. Hepatotoxicity has been reported but is very rare (<1/10,000).

HIV

Treatment of M. genitalium in HIV-positive individuals is the same as that for HIV-negative individuals.

Test of cure and follow-up

TOC is vital in ensuring microbiological clearance of infection and is recommended for all patients with confirmed M. genitalium, even if the infection was initially sensitive to macrolides, to detect resistance which may have emerged following treatment. Persistence of M. genitalium has been demonstrated in the absence of symptoms in men treated for NGU.^94,95 This occurs in about 10–20% of men treated with doxycycline, but is not associated with development of AMR.^27,95 Persistence of M. genitalium following treatment with azithromycin and moxifloxacin is strongly associated with antimicrobial resistance.^94,95

The optimal time to TOC has not been determined, but recent data suggest that very early testing after treatment when DNA load is low can give false negative results.⁹⁶ Clinical cure (i.e. resolution of symptoms) should be established at the TOC visit. The risk of re-infection should be excluded and compliance with medication should be verified.

We recommend all patients should attend for a TOC five weeks (and no sooner than three weeks in order to avoid false negative results) after the start of treatment to ensure microbiological cure and to help identify emerging resistance (1D).

Treatment failures should be reported to PHE at: https://hivstiwebportal.phe.org.uk

Footnotes

Auditable outcome measures

New cases of M. genitalium should have SHHAPT (Sexual Health and HIV Activity Property Type) code ‘C16’ submitted to GUMCAD (performance standard 97%).

Individuals treated for M. genitalium should have a TOC at least five weeks after the start of treatment (performance standard 97%).

Cases of confirmed treatment failure by positive TOC should be reported to PHE at: .

Individuals should be provided with written information about their diagnosis and management (performance standard 97%).

Partner notification (PN) should be performed and documented according to the BASHH statement on (PN) for sexually transmissible infections (performance standard 97%).

Acknowledgement

The authors would like to acknowledge Fabian Kong, Jørgen Skov Jensen, Catriona Bradshaw and Tim Read for their advice and comments on the guideline. Patrick Horner acknowledges support from the NIHR Health Protection Research Unit in Evaluation of Interventions at University of Bristol.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Editorial independence

This guideline was commissioned and edited by the Clinical Effectiveness Group (CEG) of BASHH, which also provided funding for a literature search.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Rigour of development

This guideline was produced according to specifications made in the CEG’s document 2015.

Framework for guideline development and assessment is accessible at .

Appendix 1. Example of PICO question used and list of all PICO questions

What are the optimal specimen types for testing for M. genitalium in men and women?

	Inclusion	Exclusion
Period of publication	Jan 2010 to Jun 2017
Study design/type	Meta-analysis or systematic reviewRandomised controlled trials (RCTs) Non-randomised, prospective comparative studiesProspective observational studies (e.g. cohort studies) Laboratory studies	Non-pertinent publication types (e.g. expert opinions, letters to the editor, editorials [unless include original data], comments, not referring to M. genitalium)
Study quality	Study duration (no minimum) Number of subjects (no minimum)
Study population	Adults (aged >15 years or above) in Europe, N. America, Australasia	Children (≤15 years) Adults (aged >15 years or above) outsideEurope, N. America, Australasia
Study comparison	Not applicable
Specific outcomes of interest	Sensitivity/specificityInhibitory resultsAbility to test for other STIs concurrently	No exclusions based on outcome measures

PICO questions used:

What is the prevalence of asymptomatic M. genitalium in the following populations?

Heterosexual men

Heterosexual women

MSM: HIV-negative

MSM: HIV-positive

Pregnant women

2. What is the prevalence of symptomatic M. genitalium in the following clinical presentations?

Non-gonococcal urethritis/non-specific urethritis (first presentation)

Non-gonococcal urethritis/non-specific urethritis (persistent and recurrent episodes)

Muco-purulent cervicitis/intermenstrual bleeding/post-coital bleeding

Pelvic inflammatory disease/salpingitis

Sexually-acquired proctitis

Vaginal discharge

3. What are the clinical features of M. genitalium infection?

4. What evidence is there to support testing for M. genitalium infection in the populations and clinical scenarios examined above?

5. What are the optimal specimen types for testing for M. genitalium in men and women?

6. What is the incubation/window period for M. genitalium detection?

7. What assays are available for the detection of M. genitalium?

8. What are the rates of microbiological cure/clearance rate/clinical cure/treatment failure for each of the following antimicrobial regimens?

Azithromycin (all regimens)

Moxifloxacin

Other quinolones

Tetracyclines (inc. doxycycline)

Pristinamycin

Other macrolides

9. What are the pharmacological characteristics of the following antimicrobials in the context of treatment of M. genitalium?

Azithromycin (all regimens)

Moxifloxacin

Other quinolones

Tetracyclines (inc. doxycycline)

Pristinamycin

Other macrolides

10. Is a test of cure required, and if so, what is the optimal time to conduct a test-of-cure following treatment?

11. How should the partners of patients with M. genitalium infection be managed?

Appendix 2. NICE equality impact assessment

Were any potential equality issues with respect to age, disability, gender, race, pregnancy and sexual orientation been identified before or during consultation, and, if so what are they?

The guideline is intended for the treatment of individuals aged 16 years and older. M. genitalium is more common in men and women of black ethnicity but this has not influenced the recommendations for testing. The patient information leaflet (PIL) is written in English and was piloted in English-speaking patients only. No issues were raised with respect to disability, gender, pregnancy and sexual orientation. Care has been taken to include the correct anatomical site-specific terminology rather than gender terminology for specimen taking and there is a separate section for management of M. genitalium in pregnancy

Have any changes to the scope been made as a result of consultation to highlight potential equality issues? No

Is the primary focus of the guideline a population with a specific disability-related communication need? No

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British Association for Sexual Health and HIV national guideline for the management of infection with Mycoplasma genitalium (2018)

Abstract

Keywords

Introduction

Search strategy

Equality impact assessment

Stakeholder involvement, piloting and feedback

Patient and public involvement

Microbiology

Epidemiology

Prevalence in general population and risk factors for infection

Sexual transmission

Co-infection with other STIs

Clinical associations

Non-gonococcal urethritis

M. genitalium in the female reproductive tract

Asymptomatic infection

Clinical features

Signs and symptoms in males 3

Complications in males

Signs and symptoms in females

Complications in females

Recommendations for testing

Based on symptoms

Based on risk factors

Diagnosis

Specimen collection

Men

Women

Considerations for people following gender reassignment surgery

Recommendations

Window period

Management

General advice

Treatment of uncomplicated urogenital infection (urethritis, cervicitis)

Treatment of complicated urogenital infection (PID, epididymo-orchitis)

Partner notification

Alternative regimens

Rectal infection

Sourcing of unlicensed products

Pregnancy and breastfeeding

Pregnancy

Breastfeeding

Adverse events

HIV

Test of cure and follow-up

Footnotes

Auditable outcome measures

Acknowledgement

Declaration of conflicting interests

Editorial independence

Funding

Rigour of development

Appendix 1. Example of PICO question used and list of all PICO questions

Appendix 2. NICE equality impact assessment

References

Signs and symptoms in males³