Bactericidal Efficacy Assessment of Tinidazole and Doxycycline against Mycoplasma genitalium

JRCT ID: jRCTs031230381

Registered date:06/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mycoplasma genitalium
• Date of first enrollment: 23/10/2023
• Target sample size: 44
• Study type: Interventional
• Intervention(s): Oral administration of tinidazole 2,000mg for 3 days and doxycycline 200mg for 7 days will be carried out for the participants who tested positive for Mycoplasma genitalium.

Outcome(s)

Primary Outcome

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

Secondary Outcome

The change of bacterial load before and after treatment.New resistance mutation detection rate
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.
The rate of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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).

Exclude 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.

Related Information

• Primary Sponsor: Ando Naokatsu
• Source(s) of Monetary Support: National Center for Global Health and Medicine