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A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men

A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men - A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060176
Enrollment
100
Registered
2025-12-23
Start date
2024-01-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Non-gonococcal Urethritis

Interventions

Patients with non-gonococcal urethritis should receive minocycline 100 mg orally twice daily for 7 days. If testing at the start of minocycline therapy is positive for M. genitalium, sitafloxacin 100

Sponsors

Sapporo Medical University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Symptoms: Patients presenting with symptoms of non-gonococcal urethritis. Pyuria: Cases meeting any of the following criteria for pyuria prior to initiation of medication. Using non-centrifuged urine with a designated device: >=10 WBCs/uL Using non-centrifuged urine with a urine test strip method (based on esterase activity measurement): Positive Urinalysis sediment microscopy: >=5 WBCs/hpf

Exclusion criteria

Exclusion criteria: 1) Patients who received other antimicrobial agents prior to study drug initiation and whose symptoms were already improving 2) Patients who received tetracycline-class antimicrobial agents within one week prior to study drug initiation 3) Patients with severe underlying diseases or complications that would make it difficult to evaluate the efficacy and safety of the study drug 4) Patients with a history of allergy to tetracycline-class antimicrobial agents 5) Patients with severe cardiac dysfunction or hepatic dysfunction 6) Patients with moderate or greater renal impairment (serum creatinine >= 2 mg/dL as a guideline) 7) Other patients deemed unsuitable by the attending physician

Design outcomes

Primary

MeasureTime frame
Efficacy and Safety 21 to 28 Days After Initiation of Minocycline Treatment

Countries

Japan

Contacts

Public ContactMitsuru Yasuda

Sapporo Medical University School of Medicine Department of Infection Control & Laboratory Medicine

yasuda7jpe@sapmed.ac.jp+81-11-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026