Mycoplasma genitalium infection Mycoplasma genitalium
Conditions
Interventions
After enrollment, protocol treatment will begin on the day of enrollment. The treatment period (administration period) will be 1 day.
T-4288 low-dose group: Solithromycin 1200 mg - 1 time
T-4288 high-
C547755
Sponsors
Ando Naokatsu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Age: 18 years or older (at the time of obtaining consent) (2) Gender: Male (3) Patients in whom M. genitalium genes were detected by PCR testing or other methods from urine or rectal specimens within 30 days prior to obtaining consent (4) Patients who can take the investigational drug as specified in the clinical trial protocol and can undergo observations and examinations (5) Patients who agree to refrain from sexual intercourse with partners during the trial period, or who agree to use condoms if they have sexual intercourse during the trial period (6) Patients from whom written consent can be obtained
Exclusion criteria
Exclusion criteria: (1) Patients requiring treatment with other systemic antimicrobials (2) Patients who received systemic antimicrobials after M. genitalium genes were detected by PCR testing or other methods from urine or rectal specimens (3) Patients with gastrointestinal disorders that may affect the absorption of the investigational drug, such as those who have had partial or total gastrectomy (4) Patients with eGFR less than 60 (5) Patients with serious cardiac disease (6) Patients with liver dysfunction with AST or ALT levels at least twice the upper limit of the institutional reference range, or bilirubin at least 1.5 times the upper limit of the institutional reference range (7) Patients with concurrent hepatitis B or hepatitis C (8) Patients with underlying diseases or complications that would make it difficult to evaluate the progress of the clinical trial or the safety or efficacy of the investigational drug (such as poorly controlled diabetes despite medication, progressive or terminal cancer, severe congestive heart failure, etc.) (9) Patients with mitochondrial disease (Charcot-Marie-Tooth disease, Alpers-Huttenlocher syndrome, or diseases that genetically impair mitochondrial function) (10) Patients with myasthenia gravis (11) Patients with a history of allergy to macrolide or ketolide antibiotics (12) Patients taking anti-HIV drugs that induce, inhibit, or are metabolized by cytochrome (CYP) 3A4 and have a narrow therapeutic range (13) Patients who need to take prohibited concomitant medications from the start of the investigational drug administration until the TOC visit (or at discontinuation) (14) Patients who received other investigational drugs within 90 days prior to the start of the investigational drug administration (15) Patients who have previously received solithromycin (T-4288) (16) Patients deemed ineligible by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriological efficacy by subject at TOC | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Bacteriological efficacy by subject at Day 3 and Day 8 (2) Bacteriological efficacy by infection site (3) Changes in clinical symptoms | — |
Contacts
Public ContactTomoe Morita
National Center for Global Health and Medicine, Japan Institute for Health Security
Outcome results
None listed