Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062534) titled 'A study comparing whether doxycycline (7 or more days orally) or single-dose azithromycin is less likely to require retreatment for uncomplicated genital chlamydia infection, using health insurance claims data (target trial emulation; the primary population is men)' on Aug. 10.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka, Graduate School of Medicine Faculty of Medicine

Condition: Condition - Uncomplicated genital Chlamydia trachomatis infection. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Using the JMDC insurer claims database, to compare, for outpatient treatment of uncomplicated genital chlamydia infection, a strategy of starting oral doxycycline (initial supply of 7 or more days) at Day 0 versus a strategy of starting single-dose azithromycin, and to estimate the difference in 30-day retreatment risk within a target trial emulation framework. The primary estimand is the average treatment effect in the overlap population (ATO) by propensity-score overlap weighting; the primary population is men and women are a secondary population. This registration is performed before analysis and without reference to outcomes (after outcome-blinded feasibility). Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 15 years-old = Gender - Male and Female Key inclusion criteria - (1) Treatment initiation at Day 0 with an eligible regimen (Strategy A: oral doxycycline, initial supply 7 or more days, daily dose 100-200 mg; or Strategy B: single-dose oral azithromycin). (2) Age 15-49 years. (3) No other oral anti-chlamydial drug and no same-day use of both strategies. (4) Outpatient index episode. (5) A non-suspect eligible chlamydia diagnosis (A56.0 group, etc.) from Day -14 to Day 0. (6) A chlamydia-specific test claim (nucleic acid or antigen; antibody testing not allowed) from Day -14 to Day 0. (7) No anti-chlamydial drug from Day -30 to Day -1 (new-user washout). (8) For women, no overlapping pregnancy episode. (9) No active complication (PID, epididymitis, LGV, etc.) from Day -7 to Day 0. (10) No extragenital infection (rectal, pharyngeal, ocular) from Day -14 to Day 0. (11) At least 365 days of continuous enrollment from Day -365 to Day 0. (12) Only the first eligible episode per person. The primary analytic period is 2014 Q1 to 2025 Q1. The primary population is men; women are a secondary population. JMDC insurer claims database (2005-2025) is used. Key exclusion criteria - No treatment initiation with an eligible regimen. Age outside 15-49 years. Another oral anti-chlamydial drug or same-day use of both strategies. Inpatient index. Only a suspected diagnosis, or no eligible chlamydia test. Anti-chlamydial drug use from Day -30 to Day -1 (not a new user). Overlapping pregnancy episode in women. Active complication (PID, epididymitis, LGV, complicated chlamydia). Extragenital infection. Less than 365 days of continuous enrollment. Target Size - 71272

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 14 Day Date of IRB - 2026 Year 04 Month 14 Day Anticipated trial start date - 2026 Year 08 Month 10 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=R000071588

Disclaimer: Curated by HT Syndication.