"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"

Conditions

• Mycoplasma Genitalium
• Non-gonococcal Urethritis (NGU)

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tinidazole — DRUG
  2 grams orally on day one followed by 500mg orally twice daily on days 2-10

Study Details

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.

Key Dates

Start date

Jul 23, 2025

Status verified

Apr 2026

Primary completion

Aug 1, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tinidazole
  Single Arm

Primary Outcome Measure

Microbiologic cure of M. genitalium [ Time Frame: Day 38 ]

Central Contacts

• Lisa Manhart, PhD, MPH
  206 744-3646
  [email protected]

Locations (1)

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