Tinidazole for Mycoplasma Genitalium

(SHAZAM Trial)

Overseen By Bella Lee

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Washington

Disqualifiers: Allergy to tinidazole, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 10 days

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tinidazole to determine its effectiveness in treating Mycoplasma genitalium (MG), an infection linked to non-gonococcal urethritis (NGU) in men. Although tinidazole is approved for other infections, this study explores its potential against MG. All participants will receive tinidazole in this single-treatment trial. Men diagnosed with NGU and a confirmed MG infection in the past week, who can return for a follow-up test 21 days after treatment, are suitable candidates. As a Phase 2 trial, this research measures tinidazole's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that tinidazole is likely to be safe for humans?

Research has shown that tinidazole is generally safe for treating certain infections. The FDA approved it in 2004 for conditions such as trichomoniasis and bacterial vaginosis, and most patients tolerate it well. Although specific data on using tinidazole for Mycoplasma genitalium (MG) infections is not yet available, the dosage planned in this study does not significantly increase risk. This suggests tinidazole could be a safe option for MG, but further research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Mycoplasma genitalium?

Unlike the standard treatments for Mycoplasma genitalium, which typically include antibiotics like azithromycin and doxycycline, tinidazole offers a different approach. Tinidazole is unique because it is an anti-parasitic and anti-protozoal medication, which might provide a new mechanism to target this stubborn infection. Researchers are excited about tinidazole because it could potentially overcome resistance issues seen with current antibiotics, offering a promising alternative for those who don't respond to existing therapies.

What evidence suggests that tinidazole might be an effective treatment for Mycoplasma genitalium?

Research has shown that tinidazole effectively treats infections like trichomoniasis and bacterial vaginosis, but it has not been widely tested for Mycoplasma genitalium (MG). Some similar drugs, such as metronidazole, have improved cure rates for related conditions. Current treatments for MG, like azithromycin, are losing effectiveness, highlighting the need for new options like tinidazole. Although no direct evidence exists for tinidazole's effectiveness against MG yet, its success with similar infections makes it a candidate worth exploring. Participants in this trial will receive tinidazole to evaluate its effectiveness against MG. ^{1 4 6 7 8}

Who Is on the Research Team?

Lisa Manhart, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

The SHAZAM trial is for male patients diagnosed with non-gonococcal urethritis (NGU) at the PHSKC Sexual Health Clinic. Participants should have a confirmed case of Mycoplasma genitalium infection and be willing to take tinidazole, which is not yet approved for this specific condition but has been used for similar infections.

Inclusion Criteria

Urogenital MG documented by a positive NAAT in the prior 7 days

Fluent in English

Attending the PHSKC SHC

Exclusion Criteria

Known allergy to tinidazole

At the clinician's discretion

I have no health reasons preventing me from taking tinidazole.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive tinidazole 2 grams orally on day one followed by 500mg orally twice daily on days 2-10

10 days

1 visit (in-person) at initiation

Test of Cure

Participants undergo a test of cure 21 days after completing the tinidazole regimen to determine microbiologic cure

21 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tinidazole

Trial Overview This study tests the effectiveness of tinidazole in treating Mycoplasma genitalium among men with NGU. The drug is already FDA-approved for other infections like trichomoniasis and giardiasis, but its efficacy against M. genitalium hasn't been systematically evaluated before.

How Is the Trial Designed?

Group I: Tinidazole Experimental Treatment 1 Intervention

Single Arm

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Hologic, Inc.

Industry Sponsor

Trials

48

Recruited

59,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07088419

"Sexual Health Assessment of TinidaZole Against M. ... Study Overview. Brief Summary. The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10112249/

In Vitro Susceptibility and Resistance of Mycoplasma ... A recent clinical trial suggested that metronidazole may improve cure rates for women with pelvic inflammatory disease and reduced the detection ...

3. academic.oup.com academic.oup.com/cid/article/61/suppl_8/S802/345300

Efficacy of Antimicrobial Therapy for Mycoplasma genitalium ... Randomized trials demonstrated poor efficacy of doxycycline and better, but declining, efficacy of single-dose azithromycin therapy.

4. wwwnc.cdc.gov wwwnc.cdc.gov/eid/article/28/8/22-0094_article

Weighing Potential Benefits and Harms of Mycoplasma ... This regimen had limited effectiveness against M. genitalium; cure rates were as low as 56% (69,82). More recent data demonstrated cure rates of ≈95% for PID ...

5. journals.asm.org journals.asm.org/doi/abs/10.1128/aac.00006-23

In Vitro Susceptibility and Resistance of Mycoplasma ... A recent clinical trial suggested that metronidazole may improve cure rates for women with pelvic inflammatory disease and reduced the detection ...

6. std.uw.edu std.uw.edu/pdf/comprehensive-study/mycoplasma-genitalium/core-concept/all

Mycoplasma genitalium - Core Concepts Omadacycline and tinidazole are FDA-approved antibiotics, with in vitro data suggesting they may be effective against M. genitalium.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4454211/

Mycoplasma genitalium infection: current treatment options ... Treatment was initiated with either doxycycline (200 mg on day 1, 100 mg daily on days 2–9) or azithromycin 1 g as a single dose. Those who tested positive for ...

8. drugs.com drugs.com/monograph/tinidazole.html

Tinidazole Monograph for Professionals Safety and efficacy not established in pediatric patients ≤3 years of age. Some data available regarding safety and efficacy for treatment of ...