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Bactericidal Efficacy Assessment of Tinidazole and Doxycycline against Mycoplasma genitalium

Bactericidal Efficacy Assessment of Tinidazole and Doxycycline against Mycoplasma genitalium - BEAT-MG Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230381
Enrollment
44
Registered
2023-10-06
Start date
2023-10-23
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoplasma genitalium Mycoplasma genitalium, Nitroimidazole, Tinidazole, 23S-rRNA, parC, gyrA, Urithritis, Proctitis, Cervicitis, Sexually transmitted infections,

Interventions

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.

Sponsors

Ando Naokatsu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactAndo Naokatsu

National Center for Global Health and Medicine, Japan Institute for Health Security

ando.n@jihs.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026