NCT07853742

Brief 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 condition.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
6mo left

Started Oct 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Apr 2027

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Mycoplasma Genitalium InfectionUrethritis

Keywords

Omadacycline

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 35 (+/- 7 days), 21 days after completion of the 14-day omadacycline course

Secondary Outcomes (2)

  • Safety and Tolerability of omadacycline

    At 14 (+/- 5 days) and 35 days (+/- 7 days) after study drug administration

  • Number of Participants with One or More Treatment-Emergent Adverse Events

    Day 1 (first dose administration) through Day 35 (+/- 7 days)

Study Arms (1)

Prospective Cohort

EXPERIMENTAL

Patients will receive 28 tablets of 150 mg omadacycline, taken as 300 mg daily for 14 days.

Drug: Omadacycline Oral Tablet

Interventions

Omadacycline Oral TabletDRUG

Patients will receive 28 tablets of 150 milligrams (mg) of omadacycline, taken as 300 mg daily for 14 days.

Also known as: Nuzyra
Prospective Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Oval Center at Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (4)

  • 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.

    PMID: 36314935BACKGROUND

  • Patel 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.

    PMID: 41918853BACKGROUND

  • Workowski 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.

    PMID: 34292926BACKGROUND

  • Hedstrom 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.

    PMID: 27657536BACKGROUND

MeSH Terms

Conditions

Urethritis

Interventions

omadacycline

Condition Hierarchy (Ancestors)

Urethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Eric A Meyerowitz, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric A Meyerowitz, MD

CONTACT

718-882-5482emeyerowit@montefiore.org

Caroline Mullis, MD, MS

CONTACT

718-882-5482cmullis@montefiore.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)