Bactericidal Efficacy Assessment of Tinidazole and Doxycycline against Mycoplasma genitalium

Phase 2

Recruiting

• Conditions: Mycoplasma genitalium; Mycoplasma genitalium, Nitroimidazole, Tinidazole, 23S-rRNA, parC, gyrA, Urithritis, Proctitis, Cervicitis, Sexually transmitted infections,; D045704

• Registration Number: JPRN-jRCTs031230381
• Lead Sponsor: Ando Naokatsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-06
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Individuals who were adults over 18 years old at the time of consent.
2. Individuals who tested positive for Mycoplasma genitalium in urine samples, vaginal swabs, or anal swabs.
3. Individuals who obtained written consent for participation in the study.
4. Individuals confirmed to have resistance to macrolides and quinolones, or those who are thought to be at high risk based on epidemiological information (such as a history of treatment failure with sitafloxacin and moxifloxacin, MSM).

Exclusion Criteria

1. Individuals with allergies to the treatment drugs.
2. Pregnant or breastfeeding individuals.
3. Individuals who cannot abstain from alcohol during treatment
4. Anyone else deemed inappropriate for study participation by the primary researcher.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Success Rate<br>The definition of treatment success is confirmed by a negative result in the nucleic acid amplification test during the cure confirmation examination.

Secondary Outcome Measures

Name	Time	Method
The change of bacterial load before and after treatment.New resistance mutation detection rate<br> A 'new resistance mutation detection' is defined as the occurrence of a resistant mutation in the post-treatment resistance test, which was not present in the resistance test at the time of registration.<br>The rate of adverse events.