Tokyo, Dec. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060176) titled 'A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men' on Dec. 23.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Sapporo Medical University School of Medicine
Condition:
Condition - Non-gonococcal Urethritis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - A Study on the Efficacy and Safety of Minocycline and Sitafloxacin for Non-gonococcal Urethritis in Men
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 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 mg should be added orally twice daily for an additional 7 days.
Eligibility:
Age-lower limit - 16
years-old
=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
Key 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
Target Size - 100
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2023 Year 05 Month 22 Day
Date of IRB - 2024 Year 01 Month 11 Day
Anticipated trial start date - 2024 Year 01 Month 11 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068822
Disclaimer: Curated by HT Syndication.
