Mycoplasma Genitalium InfectionPhase 2NCT07853742
Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis
A Phase 2 study testing Omadacycline Oral Tablet in people with Mycoplasma Genitalium Infection and Urethritis, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Urethritis from Mycoplasma genitalium is difficult to treat and often does not respond to first line therapy. In this case series study, individuals who have failed first line therapy will receive omadacycline (provided by Paratek Pharmaceuticals) to determine the safety and feasibility of using this agent for this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycoplasma Genitalium Infection, Urethritis
- What is being tested?
- Omadacycline Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Symptomatic urethritis (dysuria, urethral discomfort, pain, or discharge) from Mgen (exclusion of Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis by NAAT)
- Treatment-refractory infection, defined as persistent symptoms and Mgen NAAT positivity ≥21 days after completion of initial treatment. Initial treatment based on Centers for Disease Control and Prevention (CDC) guidelines: doxycycline (100 mg twice daily for seven days) followed by moxifloxacin (400 mg once daily for seven days)
Who cannot join
- Pregnancy or breast feeding
- Allergy or severe intolerance to omadacycline or any of its components
- Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), as determined on screening visit liver function tests (LFTs).
- Baseline total bilirubin > 1.5 × ULN
- Suspected or confirmed clinical evidence of end-stage liver disease (e.g., ascites, hepatic encephalopathy)
- Patient reported condomless sexual activity occurring between completion of first-line Mgen treatment and subsequent positive NAAT test
Show all 9Show fewer
- Inability of the patient to reasonably expect to avoid condomless sex during the study's 35-day follow-up period between starting study omadacycline and date of follow up test
- Based on investigator judgement, significant uncertainty about adherence to prior first-line treatments
- Based on investigator judgement, significant uncertainty about the subject's interest in or ability to adhere to omadacycline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Oval Center at Montefiore Medical Center
The Bronx, New York, 10467
Eric Meyerowitz, MD, 718-882-5482, emeyerowit@montefiore.org
Caroline Mullis, MD, MS, 718-882-5482, cmullis@montefiore.org
About this study
Urethritis from Mycoplasma genitalium is difficult to treat and often does not respond to first line therapy. In this case series study, individuals who have failed first line therapy will receive omadacycline (provided by Paratek Pharmaceuticals) to determine the safety and feasibility of using this agent for this condition.
Read the detailed description
Treatment refractory Mycoplasma genitalium (Mgen) urethritis is an extremely difficult-to-manage clinical entity with inadequate therapeutic options. There are no guidelines for management of patients who fail first-line therapy, with case reports and case series providing limited data into second-line/salvage therapy. In vitro data suggests omadacycline may be active against Mgen and a recent case report provided details on the first refractory case of Mgen cured after omadacycline. In this study individuals with symptomatic Mgen urethritis who have failed first-line therapy (doxycycline followed by moxifloxacin) will receive treatment with omadacycline. The goals of the study are to further explore the efficacy and safety of omadacycline as second-line/salvage therapy in similar cases and to potentially build a foundation for subsequent studies.
- Conditions
- Mycoplasma Genitalium Infection, Urethritis
- Being tested
- Omadacycline Oral Tablet
- Keywords
- Omadacycline
- Medical subject headings
- Urethritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omadacycline Oral TabletDrug
Also called Nuzyra
Patients will receive 28 tablets of 150 milligrams (mg) of omadacycline, taken as 300 mg daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Experimental | Patients will receive 28 tablets of 150 mg omadacycline, taken as 300 mg daily for 14 days. Receives: Drug: Omadacycline Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Microbiological Cure of Mycoplasma genitalium
Microbiological cure is defined as having a negative nucleic acid amplification test (NAAT) for Mycoplasma genitalium at the Day 35 test of cure visit. The NAAT is performed on a self-collected urine specimen or a urogenital swab. Participants with a positive NAAT result are classified as not cured (continue to have an active infection). Participants who do not attend the Day 35 (+/- 7 days) visit or from whom no evaluable specimen is obtained are classified as not cured. The denominator is all enrolled participants who received at least one dose of omadacycline. If any participants included in the study are unable to complete the full 14 days of the medication for any reason they will be evaluated based on their outcome from their Day 35 NAAT.
Measured: Day 35 (+/- 7 days), 21 days after completion of the 14-day omadacycline course
Secondary outcomes (2)
Safety and Tolerability of omadacycline
Safety and tolerability of omadacycline will be assessed in tandem using the 20-item PHArmacotherapeutical Symptom Evaluation (PHASE-20) rating scale. The scale consists of 19 specific potential drug-related symptoms plus 1 open-ended category and evaluates whether symptoms experienced during the follow-up period may be related to the medication. For each item, participants will be asked to "tick the box" that best describes symptoms they experienced over the last 2 weeks and circle the appropriate term(s) when a multi-symptom item is presented if all symptoms don't apply. Each of the 20 items is rated on a 4-point ordinal scale: 0 (No problem), 1 (Minor problem), 2 (Moderate problem), and 3 (Severe problem), yielding an overall possible score of 0-60 with higher scores being indicative of a greater burden of possible medication-related symptoms. The scale is administered by telephone at Day 14 and in person at Day 35. Scores are reported separately at each time point.
Measured: At 14 (+/- 5 days) and 35 days (+/- 7 days) after study drug administration
Number of Participants with One or More Treatment-Emergent Adverse Events
A treatment-emergent adverse event (TEAE) is defined as any adverse event with onset on or after the first dose of omadacycline. Events are identified by the investigator team assessment during the Day 14 (+/- 5 days) telephone contact and the Day 35 (+/- 7 days) clinic visit, and by participant-initiated reporting at any time during the study period. Each event is characterized by severity and by investigator-assessed relationship to omadacycline. Participants reporting more than one event are counted once.
Measured: Day 1 (first dose administration) through Day 35 (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mycoplasma Genitalium InfectionStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Paratek Pharmaceuticals Inc
- Responsible party
- Sponsor
- Investigators
- Eric A Meyerowitz, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853742
- Sponsor's protocol ID
- 2026-504
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waites KB, Crabb DM, Atkinson TP, Geisler WM, Xiao L. Omadacycline Is Highly Active In Vitro against Mycoplasma genitalium. Microbiol Spectr. 2022 Dec 21;10(6):e0365422. doi: 10.1128/spectrum.03654-22. Epub 2022 Oct 31.
PubMed 36314935Patel NM. Case Report: First In-Human Report of Cure of Refractory Mycoplasma genitalium Infection With Omadacycline. Open Forum Infect Dis. 2026 Mar 30;13(Suppl 2):S1398-S1401. doi: 10.1093/ofid/ofag030. eCollection 2026 Apr.
PubMed 41918853Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
PubMed 34292926Hedstrom M, Carlsson M, Ekman A, Gillespie U, Mork C, Asberg KH. Development of the PHASE-Proxy scale for rating drug-related signs and symptoms in severe cognitive impairment. Aging Ment Health. 2018 Jan;22(1):53-60. doi: 10.1080/13607863.2016.1232364. Epub 2016 Sep 22.
PubMed 27657536
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis
- ClinicalTrials.gov ID
- NCT07853742
- Acronym / sponsor ID
- 2026-504
- Conditions
- Mycoplasma Genitalium Infection, Urethritis
- Keywords
- Omadacycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Paratek Pharmaceuticals Inc
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urethritis from Mycoplasma genitalium is difficult to treat and often does not respond to first line therapy. In this case series study, individuals who have failed first line therapy will receive omadacycline (provided by Paratek Pharmaceuticals) to determine the safety and feasibility of using this agent for this condition.
Detailed description
Treatment refractory Mycoplasma genitalium (Mgen) urethritis is an extremely difficult-to-manage clinical entity with inadequate therapeutic options. There are no guidelines for management of patients who fail first-line therapy, with case reports and case series providing limited data into second-line/salvage therapy. In vitro data suggests omadacycline may be active against Mgen and a recent case report provided details on the first refractory case of Mgen cured after omadacycline. In this study individuals with symptomatic Mgen urethritis who have failed first-line therapy (doxycycline followed by moxifloxacin) will receive treatment with omadacycline. The goals of the study are to further explore the efficacy and safety of omadacycline as second-line/salvage therapy in similar cases and to potentially build a foundation for subsequent studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | Experimental | Drug: Omadacycline Oral TabletPatients will receive 28 tablets of 150 mg omadacycline, taken as 300 mg daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Symptomatic urethritis (dysuria, urethral discomfort, pain, or discharge) from Mgen (exclusion of Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis by NAAT)
- Treatment-refractory infection, defined as persistent symptoms and Mgen NAAT positivity ≥21 days after completion of initial treatment. Initial treatment based on Centers for Disease Control and Prevention (CDC) guidelines: doxycycline (100 mg twice daily for seven days) followed by moxifloxacin (400 mg once daily for seven days)
Key exclusion criteria (9 listed)
- Pregnancy or breast feeding
- Allergy or severe intolerance to omadacycline or any of its components
- Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), as determined on screening visit liver function tests (LFTs).
- Baseline total bilirubin > 1.5 × ULN
- Suspected or confirmed clinical evidence of end-stage liver disease (e.g., ascites, hepatic encephalopathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omadacycline Oral TabletAlso: NuzyraPatients will receive 28 tablets of 150 milligrams (mg) of omadacycline, taken as 300 mg daily for 14 days. | Drug | Prospective Cohort |
Primary outcome
Percentage of Participants with Microbiological Cure of Mycoplasma genitalium
Time frame: Day 35 (+/- 7 days), 21 days after completion of the 14-day omadacycline course
Microbiological cure is defined as having a negative nucleic acid amplification test (NAAT) for Mycoplasma genitalium at the Day 35 test of cure visit. The NAAT is performed on a self-collected urine specimen or a urogenital swab. Participants with a positive NAAT result are classified as not cured (continue to have an active infection). Participants who do not attend the Day 35 (+/- 7 days) visit or from whom no evaluable specimen is obtained are classified as not cured. The denominator is all enrolled participants who received at least one dose of omadacycline. If any participants included in the study are unable to complete the full 14 days of the medication for any reason they will be evaluated based on their outcome from their Day 35 NAAT.
2 secondary outcomes
Safety and Tolerability of omadacycline
Time frame: At 14 (+/- 5 days) and 35 days (+/- 7 days) after study drug administration
Number of Participants with One or More Treatment-Emergent Adverse Events
Time frame: Day 1 (first dose administration) through Day 35 (+/- 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 36314935Waites KB, Crabb DM, Atkinson TP, Geisler WM, Xiao L. Omadacycline Is Highly Active In Vitro against Mycoplasma genitalium. Microbiol Spectr. 2022 Dec 21;10(6):e0365422. doi: 10.1128/spectrum.03654-22. Epub 2022 Oct 31.
- Background: PubMed 41918853Patel NM. Case Report: First In-Human Report of Cure of Refractory Mycoplasma genitalium Infection With Omadacycline. Open Forum Infect Dis. 2026 Mar 30;13(Suppl 2):S1398-S1401. doi: 10.1093/ofid/ofag030. eCollection 2026 Apr.
- Background: PubMed 34292926Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1.
- Background: PubMed 27657536Hedstrom M, Carlsson M, Ekman A, Gillespie U, Mork C, Asberg KH. Development of the PHASE-Proxy scale for rating drug-related signs and symptoms in severe cognitive impairment. Aging Ment Health. 2018 Jan;22(1):53-60. doi: 10.1080/13607863.2016.1232364. Epub 2016 Sep 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric A Meyerowitz, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omadacycline Oral Tablet in people with Mycoplasma Genitalium Infection and Urethritis, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric A Meyerowitz, MD (718-882-5482, emeyerowit@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Microbiological Cure of Mycoplasma genitalium (time frame: Day 35 (+/- 7 days), 21 days after completion of the 14-day omadacycline course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07853742, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.