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Mycoplasma genitalium Management in Adults

Lead Author(s): , MD, MPH and , MD. Writing Group: , MD, FACP, FIDSA, , MD, PhD, , MD, , MD, , MD, MPH, PhD, FACP, AAHIVS, , MD, and , MD, MPH; on behalf of Medical Care Criteria Committee .

Baltimore (MD): Johns Hopkins University; .

Updates, Authorship, and Related Guidelines

Developer and funding source

New York State Department of Health AIDS Institute (NYSDOH AI)

Intended users

New York State clinicians who manage sexually transmitted infection care for adults age 18 and older

Development

See Supplement: Guideline Development and Recommendation Ratings

Updates

March 28, 2022
  • References and citations updated throughout to include literature published in 2020 and 2021.
  • Recommendations updated to reflect changes published in the CDC 2021 STI Treatment Guidelines.
  • Laboratory Testing and Diagnosis: Added recommendations for testing in symptomatic patients.
  • Treatment: Added scenario-based regimens and expanded discussion of macrolide resistance.

Author and writing group conflict of interest disclosures

See Conflict of Interest statement*

Related NYSDOH AI guidelines

Guidance: Adopting a Patient-Centered Approach to Sexual Health

Purpose of This Guideline

Date of current publication: March 28, 2022 Lead authors: Daniela E. DiMarco, MD, MPH; Marguerite A. Urban, MD Writing group: Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Charles J. Gonzalez, MD; Christopher J. Hoffmann, MD, MPH Committee: Medical Care Criteria Committee Date of original publication: September 28, 2020

This guideline on management of Mycoplasma genitalium infection was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) Clinical Guidelines Program. This update reflects changes included in the Centers for Disease Control and Prevention (CDC) 2021 STI Treatment Guidelines. By addressing the care of adults with and without HIV who have acquired sexually transmitted M. genitalium, the goals of this guideline are to:

  • Assist clinicians in recognizing common clinical manifestations of M. genitalium infection.
  • Provide clinicians with evidence-based recommendations on screening, diagnostic testing, and treatment of M. genitalium infection.
  • Ensure that NYS recommendations for M. genitalium screening, diagnosis, and treatment reflect the rapidly evolving evidence regarding the organism, infection, potential complications, and implications of drug resistance.

The literature on this topic and the disease epidemiology are evolving rapidly. To prepare this guidance, the authors conducted a literature search through MEDLINE and published guidelines from multiple sources, including the CDC, International Union Against Sexually Transmitted Infections, British Association for Sexual Health and HIV, Australian Society for HIV, Viral Hepatitis and Sexual Health Medicine, and the Public Health Agency of Canada.

Although previously considered an emerging sexually transmitted infection (STI), M. genitalium infection has now become a well-recognized cause of STIs worldwide, specifically linked to urethritis, cervicitis, and pelvic inflammatory disease, yet much is still unknown about the organism, infection, and potential complications. Treatment of M. genitalium infection is challenging in an era of increasing antimicrobial resistance across multiple drug classes. Emerging antimicrobial resistance worldwide has become a concern, and updates to treatment recommendations in the United States and elsewhere have been implemented to address this issue.

Prevalence of M. genitalium infection: The prevalence of M. genitalium infection varies depending on the clinical setting and population being tested. Prevalence rates in the general U.S. population are low, reported between 1% and 4% [Torrone, et al. 2021; Manhart, et al. 2007], with higher rates (>4% to <40%) reported worldwide among individuals in STI clinic settings [Begnis, et al. 2021; Broad, et al. 2021; Calas, et al. 2021; Horseman, et al. 2021; Baumann, et al. 2018; Casin, et al. 2002]. Although these ranges are based on data from multiple countries and populations and include a mix of symptomatic and asymptomatic individuals, most reports suggest that asymptomatic infection is common [Calas, et al. 2021; Gesink, et al. 2016; Huppert, et al. 2008; Manhart, et al. 2007].

Clinical Manifestations

Although asymptomatic infection is commonly reported, M. genitalium infection has been associated with the clinical syndromes of urethritis, cervicitis, and pelvic inflammatory disease (PID). The causative relationships between M. genitalium and cervicitis and urethritis have been established, with the strongest association seen with persistent or recurrent urethritis [CDC 2021; Dehon, et al. 2016; Lis, et al. 2015; Lusk, et al. 2011; Gaydos, et al. 2009; Wikström and Jensen 2006; Mena, et al. 2002; Totten, et al. 2001]. Symptoms are typically similar to those seen with chlamydial urethritis (non-purulent urethral discharge) as opposed to gonococcal urethritis (frankly purulent discharge).

M. genitalium has been associated with PID, though the evidence is inconclusive and conflicting. A 2015 meta-analysis found a statistically significant association between M. genitalium infection and an increased risk of both cervicitis and PID, even when accounting for coinfections with other sexually transmitted infections and limiting to those that used nucleic acid amplification testing [Lis, et al. 2015]. A later meta-analysis in 2019 included a sub-analysis of 2 prospective studies that demonstrated an increased risk for PID when M. genitalium was detected, though this was not statistically significant [Cina, et al. 2019]. A randomized trial comparing the addition of metronidazole or placebo to standard PID treatment (ceftriaxone plus doxycycline) noted a statistically significant reduction in detection of M. genitalium 30 days after treatment in the metronidazole arm, despite metronidazole’s lack of activity against the organism [Wiesenfeld, et al. 2021]. Some experts suggest that these findings implicate the influence of the vaginal microbiome, which requires further investigation to determine whether M. genitalium is an independent contributor to development of PID [Mitchell, et al. 2021].

Though the organism has been discovered at multiple anatomic sites, at present there is insufficient evidence that M. genitalium is a primary cause of proctitis, and no evidence that it is a cause of pharyngitis or epididymo-orchitis. Similarly, there is insufficient evidence that M. genitalium is a cause of infertility or pregnancy complications; studies that are not serology-based are needed. The consequences of asymptomatic infections are unknown [CDC 2021].

Laboratory Testing and Diagnosis

RECOMMENDATIONS

Laboratory Testing and Diagnosis

  • Clinicians should not routinely screen for M. genitalium in asymptomatic individuals. (A3)
  • Clinicians should test for M. genitalium in individuals with persistent or recurrent urethritis or cervicitis. (B2)
  • When testing is indicated, clinicians should use nucleic acid amplification testing (NAAT) to diagnose M. genitalium infection, with resistance testing if available. (A2)

M. genitalium bacteria have no cell wall and can take months to grow in culture; thus, traditional methods of diagnosis with gram stain or culture are not useful. Diagnosis was difficult until molecular tests, such as NAAT, became available. NAAT is the preferred U.S. Food and Drug Administration (FDA)-approved diagnostic method for M. genitalium infection. The FDA-approved tests currently cleared for use on urine, endocervical, urethra, and penile meatus specimens are the Aptima Mycoplasma genitalium Assay (Hologic Inc) and Cobas TV/MG Assay (Roche Diagnostics).

The specimen and site of optimal sensitivity for testing in transgender individuals with a neopenis or neovagina have not been evaluated.

Screening: Currently available evidence does not support routine screening for M. genitalium in asymptomatic individuals or in any specific population [Golden, et al. 2017; Horner and Martin 2017], and the Centers for Disease Control and Prevention (CDC) recommends against routine screening of asymptomatic individuals [CDC 2021]. Prevalence estimates of M. genitalium in the general population are low, antimicrobial resistance is increasing, the implications of asymptomatic infection are unknown, and treatment options are limited [Fernández-Huerta, et al. 2020; Baumann, et al. 2018; Golden, et al. 2017; Horner and Martin 2017]. At present, there is insufficient evidence regarding pregnancy complications and treatment benefits to recommend for or against screening in asymptomatic pregnant individuals [Wiesenfeld and Manhart 2017].

Diagnostic testing: The recommended use of diagnostic testing for M. genitalium is largely limited to patients with persistent or recurrent symptoms. The CDC specifies that M. genitalium testing not be performed in the first round of testing for initial presenting sexually transmitted infection syndromes of cervicitis or urethritis [CDC 2021]. However, given the strong association of M. genitalium with persistent or recurrent urethritis and cervicitis, diagnostic testing is recommended in that clinical scenario.

The role of diagnostic testing for M. genitalium in the initial evaluation of pelvic inflammatory disease (PID) is unclear given the lack of robust evidence for M. genitalium as an independent cause of PID. This committee suggests limiting M. genitalium testing in those with PID when gonococcal and chlamydial tests are negative and symptoms persist despite empiric treatment.

Some international guidelines advise that diagnostic testing for M. genitalium be performed only in individuals with symptomatic urethritis, cervicitis, or PID [ASHM 2021; Soni, et al. 2019]; others advise that testing be performed only in those with negative gonorrhea and chlamydia test results or who do not respond to first-line empiric treatment [Public Health Agency of Canada 2017; Jensen, et al. 2016]. Non-response to first-line treatment increases the index of suspicion for M. genitalium as a causative agent.

Testing of sex partners: There is little evidence to date to guide the management for sex partners of those diagnosed with M. genitalium infection. The CDC and most international guidelines suggest limiting evaluation (i.e., testing and treatment) to ongoing sex partners of those individuals diagnosed and treated for a symptomatic M. genitalium infection (see guideline section Treatment > Partner Management).

KEY POINT
  • Asymptomatic M. genitalium infection is common and its implications unclear; therefore, routine screening is not recommended, and diagnostic testing is reserved for individuals who:
    • Have persistent or recurrent urethritis or cervicitis or PID in the absence of gonorrhea or chlamydia and with persistent symptoms despite therapy
    • Are current sex partners of individuals treated for symptomatic M. genitalium infection

Resistance testing: Molecular tests that detect both M. genitalium and antibiotic-associated resistance mutations are available in some countries. These combination tests are not commercially available in the United States but are anticipated to become available in the near future. At present, resistance assays are most useful in determining macrolide resistance. The association of certain resistance mutations with clinical treatment failure is inconsistent for quinolone antibiotics [Conway, et al. 2020]. However, resistance testing has been demonstrated to be a clinically useful tool to guide treatment, resulting in high cure rates, as evidenced by the resistance-guided antimicrobial therapy model (see guideline section Treatment) [Durukan, et al. 2020].

Treatment

RECOMMENDATIONS

Treatment

  • Clinicians should treat patients with urethritis (A2), cervicitis (A2), and PID (B2) caused by M. genitalium infection as recommended in Table 1: Recommended Antimicrobial Regimens for Mycoplasma genitalium Infection Treatment.
  • When M. genitalium testing is unavailable, clinicians should treat patients when there is a high clinical index of suspicion for M. genitalium infection and other STIs have been reasonably excluded from the differential diagnosis. (B3)

Azithromycin, doxycycline, and moxifloxacin are the most frequently used antibacterial agents for M. genitalium infection treatment (see Table 1, below). Updates to treatment recommendations in the United States and elsewhere have been implemented to address the emerging concern of antimicrobial resistance across multiple drug classes. A 2015 literature review noted that treatment efficacy for both azithromycin and doxycycline has been declining [Manhart, et al. 2015]. With evidence of emerging macrolide resistance and treatment failure associated with azithromycin as a single 1-gram (g) oral dose, in 2021, the Centers for Disease Control and Prevention (CDC) recommended against use of this regimen in favor of 2-step antibiotic therapy (see discussion of 2-step treatment approach, below) [Horner, et al. 2018; Gesink, et al. 2016; Manhart, et al. 2013].

Though moxifloxacin once had documented cure rates approaching 100%, some studies report a rate <90% with monotherapy [Li, et al. 2017; Manhart, et al. 2015]. In the 2015 literature review noted above, levofloxacin and ofloxacin had lower cure rates than 4th-generation quinolones, including moxifloxacin, gatifloxacin, and sitafloxacin [Manhart, et al. 2015]. A meta-analysis of primarily observational studies compared the efficacy of 7- and 10-day treatment durations for moxifloxacin and found no significant difference [Li, et al. 2017]. For PID related to M. genitalium or the PID clinical syndrome in general, a 14-day course of moxifloxacin treatment was found to be effective [Ovens, et al. 2020; Latimer, et al. 2019; Judlin, et al. 2010; Ross, et al. 2006]. Because of emerging resistance overall and a lack of treatment alternatives, Australian, Canadian, and European STI guidelines do not recommend moxifloxacin for first-line empiric treatment of M. genitalium infection [ASHM 2021; Soni, et al. 2019; Public Health Agency of Canada 2017; Jensen, et al. 2016].

Macrolide Resistance

The prevalence of macrolide-associated resistance mutations is >50% in many areas and was >62% in an STI clinic population in the United States [Bachmann, et al. 2020]. Risk factors for macrolide-associated resistance mutations include male-to-male sexual contact, recent STI, STI coinfection, and use of antibiotics within the previous 30 days [Bercot, et al. 2021; Broad, et al. 2021; De Baetselier, et al. 2021; de Salazar, et al. 2021; Li, et al. 2020; Latimer, et al. 2020; Anagrius, et al. 2013].

In cases of treatment failure with macrolides and moxifloxacin, pristinamycin 1 g 4 times per day for 10 days has been found effective in European and Australian studies [Read, et al. 2018; Bissessor, et al. 2015]; however, this treatment is not commercially available in the United States.

2-step treatment approach: With evidence of emerging macrolide resistance and treatment failure associated with azithromycin as a single 1 g oral dose [Horner, et al. 2018; Gesink, et al. 2016; Manhart, et al. 2013], the CDC recommends against using this regimen in favor of 2-step antibiotic therapy [CDC 2021]. The premise of the 2-step treatment approach is that pretreatment with doxycycline has been shown to decrease the overall bacterial burden, making treatment with a second follow-up drug more efficacious [Durukan, et al. 2020; Anagrius, et al. 2013; Björnelius, et al. 2008].

Published reports have shown improved antimicrobial treatment success with a 2-step approach, leading to recommendations for 2-step treatment in Australian and British treatment guidelines [ASHM 2021; Soni, et al. 2019]. In Australia, cure rates have risen to >90% with the implementation of resistance-guided therapy (RGT) [Durukan, et al. 2020]: Individuals with an STI syndrome received 7 days of oral doxycycline 100 mg twice daily empirically and then, if found to have M. genitalium infection without macrolide resistance, received 2.5 g oral azithromycin over 4 days (1 g on day 1 and 500 mg once daily on days 2 through 4). After initial treatment with doxycycline, individuals with macrolide-resistant M. genitalium infection received oral moxifloxacin 400 mg once daily for 7 days. A test of cure was performed 2 to 4 weeks after treatment. The cure rate with the RGT approach was 92%, even in regions with reported quinolone resistance of 15% to 20% [Durukan, et al. 2020].

The CDC 2021 STI Treatment Guidelines include updated treatment recommendations for uncomplicated chlamydial infections, nongonococcal urethritis, and cervicitis. First-line therapy of oral doxycycline 100 mg twice daily for 7 days replaced single-dose 1 g oral azithromycin [CDC 2021]. This change is consistent with other international guideline recommendations and facilitates use of a 2-step doxycycline-containing regimen for individuals with persistent or recurrent urethritis or cervicitis who return for follow-up. Standard empiric therapy for PID also includes doxycycline as a component. The CDC recommends that when testing results become available after treatment initiation in cases of PID attributed to M. genitalium, moxifloxacin should be added to the empiric PID regimen rather than given sequentially [CDC 2021].

Antimicrobial Treatment

Table 1, below, summarizes currently recommended treatment options.

Table 1: Recommended Antimicrobial Regimens for Mycoplasma genitalium Infection  Treatment
Selected Conditions Oral Regimens Considerations
M. genitalium Detected by FDA-Approved NAAT
Resistance testing unavailable or macrolide resistantDoxycycline 100 mg twice daily for 7 days followed by moxifloxacin 400 mg once daily for 7 days
  • Pregnant patients: Doxycycline and moxifloxacin are generally not recommended [a].
  • Preferred for PID: 14-day moxifloxacin-containing regimen [b]
Macrolide susceptible or moxifloxacin unavailableDoxycycline 100 mg twice daily for 7 days followed by azithromycin 1 g on day 1 followed by azithromycin 500 mg once daily for 3 days
  • Patients with persistent symptoms: If this regimen is used in the absence of macrolide-susceptibility testing, perform test of cure at 21 days after treatment is completed [CDC 2021].
  • Pregnant patients: Doxycycline is generally not recommended [a].
M. genitalium NAAT Unavailable
High clinical index of suspicion (other STIs should be reasonably excluded prior to initiating treatment)Doxycycline 100 mg twice daily for 7 days followed by moxifloxacin 400 mg once daily for 7 days
  • Pregnant patients: Doxycycline and moxifloxacin are generally not recommended [a].
  • Preferred for PID: 14-day moxifloxacin-containing regimen [b]

Abbreviations: FDA, U.S. Food and Drug Administration; NAAT, nucleic acid amplification testing; PID, pelvic inflammatory disease; STI, sexually transmitted infection.

Notes:

a

See guideline section Treatment > Treatment in Pregnancy, below.

b

A 14-day regimen containing moxifloxacin (400 mg per day) is effective for PID treatment [Ovens, et al. 2020; Latimer, et al. 2019; Judlin, et al. 2010; Ross, et al. 2006], in addition to an empiric 14-day regimen for PID that contains doxycycline [CDC 2021]. The evaluation and treatment of PID are not limited to the management discussed here.

Testing unavailable: Some clinical settings and care providers may not have access to M. genitalium nucleic acid amplification testing (NAAT) to guide diagnosis in the cases of persistent or recurrent urethritis or cervicitis. In these cases, empiric therapy can be prescribed when a high clinical index of suspicion for M. genitalium infection exists and other common STIs in the differential have been reasonably excluded (e.g., C. trachomatis, N. gonorrhoeae, T. vaginalis, and herpes simplex virus). Doxycycline remains the recommended first step in the treatment regimen at time of diagnosis, followed by moxifloxacin.

Test of cure: The timeframe used for test of cure in the published literature is highly variable. Existing international guidelines include recommendations ranging from ≥2 to ≥5 weeks following treatment [ASHM 2021; Soni, et al. 2019; Jensen, et al. 2016]. Testing too soon after treatment carries the risk of detecting residual noninfectious particles. The CDC recommends a test of cure at 21 days for those treated with the 2-step doxycycline plus azithromycin regimen (see Table 1, above) who did not complete macrolide-resistance testing [CDC 2021]. This committee prefers that test of cure be reserved for patients who remain symptomatic and obtained no sooner than 21 days after treatment.

STI coinfection: When coinfection with another STI is present, it remains unclear based on available evidence whether M. genitalium is a true pathogen requiring treatment. If M. genitalium is detected in a patient with another STI, this committee recommends reserving treatment for M. genitalium for those with persistent symptoms despite appropriate treatment of the other infection (e.g., gonorrhea, chlamydia, trichomoniasis).

Treatment in Pregnancy

Moxifloxacin and doxycycline are generally not recommended for pregnant individuals. An azithromycin-only course of treatment (e.g., azithromycin 1 g on day 1 followed by 500 mg once daily on days 2, 3, and 4) can be considered with acknowledgment of the risk of treatment failure (see guideline section Treatment > Macrolide Resistance, above). Given the high rates of azithromycin resistance, shared decision-making is warranted after considering the risks of untreated M. genitalium infection during pregnancy and possible adverse drug events associated with antibiotics not generally used during pregnancy.

Some studies have raised concerns about associations between M. genitalium infection and infertility and pregnancy complications, though the evidence is limited and insufficient to demonstrate causation. A meta-analysis of available studies has suggested significant associations with preterm birth and spontaneous abortion [Lis, et al. 2015]. In this same analysis, the risk of infertility was described as elevated but was not statistically significant [Lis, et al. 2015]. Existing data are from observational studies and are further limited by use of serology, which is not an appropriate diagnostic tool [CDC 2021].

Partner Management

There is insufficient evidence to clarify whether sex partners of individuals with symptomatic M. genitalium infection should receive treatment without testing or be treated only if infection is detected through a laboratory test [ASHM 2021; Soni, et al. 2019; Public Health Agency of Canada 2017; Jensen, et al. 2016]. This committee considers it reasonable to limit treatment to ongoing sex partners with positive test results, which is also supported by current CDC guidelines. The CDC recommends treating the partner with the same regimen that was provided to the patient if testing is unavailable [CDC 2021].

All Recommendations

RECOMMENDATIONS

Laboratory Testing and Diagnosis

  • Clinicians should not routinely screen for M. genitalium in asymptomatic individuals. (A3)
  • Clinicians should test for M. genitalium in individuals with persistent or recurrent urethritis or cervicitis. (B2)
  • When testing is indicated, clinicians should use nucleic acid amplification testing (NAAT) to diagnose M. genitalium infection, with resistance testing if available. (A2)

Treatment

  • Clinicians should treat patients with urethritis (A2), cervicitis (A2), and PID (B2) caused by M. genitalium infection as recommended in Table 1: Recommended Antimicrobial Regimens for Mycoplasma genitalium Infection Treatment.
  • When M. genitalium testing is unavailable, clinicians should treat patients when there is a high clinical index of suspicion for M. genitalium infection and other STIs have been reasonably excluded from the differential diagnosis. (B3)

Abbreviations: PID, pelvic inflammatory disease; STI, sexually transmitted infection.

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Footnotes

Conflict of Interest: There are no author or writing group conflict of interest disclosures.

Created: September 2020; Last Update: March 2022.

Copyright © Johns Hopkins University Clinical Guidelines Program 2000-2024. The Clinical Guidelines Program, a collaborative effort of the NYSDOH AI and the Johns Hopkins University School of Medicine, Division of Infectious Diseases, encourages the use, reproduction, and distribution of original documents and related graphics from this program website accompanied by a full citation of source that includes: Author(s). Committee. Title. Date of publication. Full URL. Date accessed. Links to pages on this Clinical Guidelines Program website are also encouraged and may be created without seeking permission. Requests to adapt material, i.e., to change or alter in any way material from this website for inclusion in another publication, should be sent to [email protected]. Please include detailed information about the intended use and desired adaptations.

This book is licensed under the terms of the Attribution-NonCommercial-NoDerivs 3.0 Unported (CC BY-NC-ND 3.0).

Bookshelf ID: NBK583532PMID: 36070499

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