Mycoplasma genitalium infecton Cervicitis, Urethritis, Proctitis, Sexually transmitted infection, Mycoplasma genitalium, Solithromycin
Conditions
Interventions
Sponsors
Ando Naokatsu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Individuals aged 18 years or older at the time of obtaining informed consent. 2. Female patients who are not pregnant, have no plans to become pregnant during the study period, and are not breastfeeding. 3. Patients in whom Mycoplasma genitalium DNA has been detected within the past 30 days in a vaginal swab, cervical swab, urine, or rectal specimen using a PCR or other nucleic acid amplification test 4. Patients who are able to take the investigational drug as specified in the study protocol and can undergo the required observations and examinations. 5. Patients who agree to abstain from sexual intercourse during the study period, or if sexual intercourse occurs, agree to use a condom during the study period. 6. Patients capable of providing written informed consent personally.
Exclusion criteria
Exclusion criteria: Patients who require treatment with other systemic antibacterial agents. Patients who have received macrolide, quinolone, or tetracycline-class antibacterial agents after detection of Mycoplasma genitalium DNA by PCR or other nucleic acid amplification tests from genital or rectal specimens. Patients with gastrointestinal disorders that may affect absorption of the investigational drug, such as partial or total gastrectomy. Patients with renal impairment requiring dosage adjustment of medications. Patients with hepatic impairment accompanied by severe cardiac disease, encephalopathy, or moderate ascites (estimated volume of approximately 3 L or more based on ultrasonography, body weight changes, or paracentesis findings). Patients with concurrent active hepatitis B or hepatitis C infection. Patients with underlying diseases or complications that may interfere with study conduct or with the assessment of safety or efficacy of the investigational drug (e.g., uncontrolled diabetes despite treatment, progressive or terminal cancer, severe congestive heart failure). Patients with mitochondrial diseases (e.g., Charcot-Marie-Tooth disease, Alpers-Huttenlocher syndrome, or genetically determined mitochondrial dysfunction). Patients with myasthenia gravis. Patients with a history of allergy to macrolide or ketolide antibiotics. Patients receiving anti-HIV drugs that are inducers, inhibitors, or narrow-therapeutic-index substrates of cytochrome (CYP) 3A4. Patients who are expected to require concomitant use of prohibited medications between the start of the investigational drug administration and the test-of-cure (TOC) visit (or discontinuation). Patients who have received any investigational drug within 90 days prior to initiation of the study treatment. Patients with a history of solithromycin (T-4288) administration. Patients deemed ineligible by the coordinating investigator, principal investigator, or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriological efficacy by subject at the Test-of-Cure visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bacteriological efficacy by subject on Day 3 2. Bacteriological efficacy by site of infection 3. Changes in clinical symptoms over time | — |
Contacts
Public ContactAndo Naokatsu
National Center for Global Health and Medicine, Japan Institute for Health Security
Outcome results
None listed