Mycoplasma GenitaliumPhase 2SHAZAMNCT07088419
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
A Phase 2 study testing Tinidazole in people with Mycoplasma Genitalium and Non-gonococcal Urethritis (NGU), run by University of Washington at 1 site in United States.
Trial summary
The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male patients who have been diagnosed with non-gonococcal urethritis (NGU) at the Public Health - Seattle \&King County (PHSKC) Sexual Health Clinic (SHC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU)
- What is being tested?
- Tinidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2025to 31 Aug 2026
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Clinical diagnosis of NGU
- Urogenital MG documented by a positive NAAT in the prior 7 days
- Fluent in English
- Assigned male at birth
- Attending the PHSKC SHC
- Able to provide informed consent
- Able to undergo a test of cure (TOC) 21 days after completing the tinidazole regimen
Who cannot join
- Known allergy to tinidazole
- Other contraindications to tinidazole
- At the clinician's discretion
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, 1 recruiting
- Recruiting
Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic
Seattle, Washington, 98104
Bella M Lee, BS, 206-744-5877, bellalee@uw.edu
Lisa E Manhart, PhD
About this study
Official title: Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male patients who have been diagnosed with non-gonococcal urethritis (NGU) at the Public Health - Seattle \&King County (PHSKC) Sexual Health Clinic (SHC). Tinidazole was approved by the Food and Drug Administration (FDA) in May 2004 to treat other infections (i.e., trichomoniasis, giardiasis, amebiasis, bacterial vaginosis) but has not been systematically tested for effectiveness against M. genitalium. The dosing that the investigators are proposing does not significantly increase the risk associated with taking tinidazole and this investigation meets criteria for an IND exemption.
Read the detailed description
To estimate the efficacy of tinidazole for treating M. genitalium among people male sex at birth (men) diagnosed with NGU, the investigators will enroll men with NGU attending an urban sexual health clinic who have a positive test for M. genitalium. Prior to enrollment, men with NGU will have received syndromic therapy for NGU consisting of doxycycline 100mg orally twice daily for 7 days. After enrollment men with NGU will receive tinidazole 2 grams orally on day one followed by 500mg orally twice daily on days 2-10. Participants will undergo a test of cure 21 days after completing the tinidazole regimen to determine whether M. genitalium has been eradicated (microbiologic cure). Remnant urine specimens from the NGU diagnosis visit will be used to perform culture and minimum inhibitory concentration (MIC) assessment, and will undergo quantitative PCR (qPCR) to determine initial organism load. Urine specimens collected at the initiation of tinidazole therapy and at the test of cure will also undergo culture, MIC assessment, and qPCR .
- Being tested
- Tinidazole
- Keywords
- Sexually Transmitted Disease (STD), Sexually Transmitted Infection (STI), Mycoplasma genitalium, Tinidazole, Non-gonococcal urethritis (NGU)
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TinidazoleDrug
2 grams orally on day one followed by 500mg orally twice daily on days 2-10
| Study group | Role | What they receive |
|---|---|---|
| Tinidazole | Experimental | Single Arm Receives: Drug: Tinidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiologic cure of M. genitalium
Microbiologic cure of M. genitalium will be determined at a test of cure visit. Microbiologic cure will be defined as a negative test for M. genitalium in a urine specimen using a nucleic acid amplification test.
Measured: Day 38
Secondary outcomes (4)
Antimicrobial susceptibility to tinidazole (MIC levels)
The investigators will culture M. genitalium and determine the MIC range for tinidazole.
Measured: baseline; day 7; day 38
Antimicrobial susceptibility to tinidazole (resistance associated mutations)
The investigators will use selective whole genome amplification to identify potential tinidazole resistance associated mutations (TRAMs).
Measured: baseline; day 7; day 38
Association of high MIC levels with treatment failure
Using results from Secondary Outcome Measure #2 (culture of M. genitalium from determination of the minimum inhibitory concentration for tinidazole), the investigators will perform statistical analyses to determine if MIC levels are correlated with treatment failure.
Measured: Day 38
Association of tinidazole resistance-associated mutations with treatment failure
Using results from Secondary Outcome Measure #3, the investigators will use statistical methods to determine if specific tindazole resistance-associated mutatons are correlated with microbiologic cure.
Measured: Day 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start23 Jul 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycoplasma GenitaliumStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Principal investigator, Lisa Manhart, University of Washington
- Investigators
- Lisa Manhart, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088419
- Sponsor's protocol ID
- STUDY00021780
- Other IDs
- None, N/A
- Acronym
- SHAZAM
- Status last verified
- Apr 2026
- First submitted
- 28 May 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will adhere to sponsor reporting requirements for IPD. The investigators will share anonymized data to qualified investigators who request it upon IRB approval. The investigators will have the University of Washington IRB review other requests for sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinidazole for Mycoplasma Genitalium-Urethritis in the Public Health - Seattle & King County Sexual Health Clinic
- ClinicalTrials.gov ID
- NCT07088419
- Acronym / sponsor ID
- SHAZAM / STUDY00021780
- Keywords
- Sexually Transmitted Disease (STD), Sexually Transmitted Infection (STI), Mycoplasma genitalium, Tinidazole, Non-gonococcal urethritis (NGU)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 28 Jul 2025 (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.
The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male patients who have been diagnosed with non-gonococcal urethritis (NGU) at the Public Health - Seattle \&King County (PHSKC) Sexual Health Clinic (SHC). Tinidazole was approved by the Food and Drug Administration (FDA) in May 2004 to treat other infections (i.e., trichomoniasis, giardiasis, amebiasis, bacterial vaginosis) but has not been systematically tested for effectiveness against M. genitalium. The dosing that the investigators are proposing does not significantly increase the risk associated with taking tinidazole and this investigation meets criteria for an IND exemption.
Detailed description
To estimate the efficacy of tinidazole for treating M. genitalium among people male sex at birth (men) diagnosed with NGU, the investigators will enroll men with NGU attending an urban sexual health clinic who have a positive test for M. genitalium. Prior to enrollment, men with NGU will have received syndromic therapy for NGU consisting of doxycycline 100mg orally twice daily for 7 days. After enrollment men with NGU will receive tinidazole 2 grams orally on day one followed by 500mg orally twice daily on days 2-10. Participants will undergo a test of cure 21 days after completing the tinidazole regimen to determine whether M. genitalium has been eradicated (microbiologic cure). Remnant urine specimens from the NGU diagnosis visit will be used to perform culture and minimum inhibitory concentration (MIC) assessment, and will undergo quantitative PCR (qPCR) to determine initial organism load. Urine specimens collected at the initiation of tinidazole therapy and at the test of cure will also undergo culture, MIC assessment, and qPCR .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tinidazole | Experimental | Drug: TinidazoleSingle Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age
- Clinical diagnosis of NGU
- Urogenital MG documented by a positive NAAT in the prior 7 days
- Fluent in English
- Assigned male at birth
Key exclusion criteria (3 listed)
- Known allergy to tinidazole
- Other contraindications to tinidazole
- At the clinician's discretion
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 |
|---|---|---|
| Tinidazole2 grams orally on day one followed by 500mg orally twice daily on days 2-10 | Drug | Tinidazole |
Primary outcome
Microbiologic cure of M. genitalium
Time frame: Day 38
Microbiologic cure of M. genitalium will be determined at a test of cure visit. Microbiologic cure will be defined as a negative test for M. genitalium in a urine specimen using a nucleic acid amplification test.
4 secondary outcomes
Antimicrobial susceptibility to tinidazole (MIC levels)
Time frame: baseline; day 7; day 38
Antimicrobial susceptibility to tinidazole (resistance associated mutations)
Time frame: baseline; day 7; day 38
Association of high MIC levels with treatment failure
Time frame: Day 38
Association of tinidazole resistance-associated mutations with treatment failure
Time frame: Day 38
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 4 May 2026.
- Individual participant dataSharing planned: Undecided. The investigators will adhere to sponsor reporting requirements for IPD. The investigators will share anonymized data to qualified investigators who request it upon IRB approval. The investigators will have the University of Washington IRB review other requests for sharing IPD.
Related trials for Mycoplasma Genitalium
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Community Burden of MG Infection
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Enrolling by invitationObservational study
Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
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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.
Lisa Manhart, PhD principal investigator
University of Washington
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 Tinidazole in people with Mycoplasma Genitalium and Non-gonococcal Urethritis (NGU), run by University of Washington 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 May 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 Lisa Manhart, PhD, MPH (206 744-3646, lmanhart@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiologic cure of M. genitalium (time frame: Day 38). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2026.