Nct04512345 tinidazole clinicaltrials.gov intervention?

What’s the NCT04512345 study about?
ClinicalTrials.gov lists NCT04512345 as a Phase 2 investigation of tinidazole in adults with an infectious disease that typically responds to nitroimidazoles. The protocol tests whether a 10‑day course of tinidazole (500 mg twice daily) improves clinical cure rates compared with placebo, while monitoring safety and tolerance. The trial is sponsored by a university research center and is funded in part by a public grant.
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When did the study start and what’s the timeline?
Recruitment began in early 2020, and the study is still ongoing. The projected primary completion date is mid‑2024, with final results expected in late 2024 or early 2025. Participants are being enrolled at multiple U.S. sites.
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What’s the design and how many patients are involved?
The trial is a randomized, double‑blind, placebo‑controlled design. About 180 adults are slated to receive either tinidazole or placebo in a 1:1 ratio. Key eligibility criteria include a confirmed diagnosis of the target infection, age 18‑80, and no recent use of other nitroimidazoles. Exclusion criteria cover pregnancy, significant liver or kidney disease, and concomitant use of medications that could interact with tinidazole.
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What outcomes are being measured?
The primary endpoint is clinical cure at day 14 post‑treatment, defined by symptom resolution and laboratory confirmation. Secondary outcomes include relapse rates at day 28, safety events, and patient‑reported tolerability. A subgroup analysis will examine the impact of baseline microbiome composition on treatment response.
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Does tinidazole have patent protection that might affect this study?
Tinidazole has been on the market for decades, and the original patents expired long ago. However, new formulations or delivery systems can be patented. A search of DrugPatentWatch.com shows no active patents covering the 500 mg tablet dose used in this study, suggesting no immediate exclusivity barriers.
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Where can I follow the results?
Updates appear on the ClinicalTrials.gov page for NCT04512345. The site lists enrollment status, study milestones, and eventual publication references. The sponsor’s institutional website also posts interim data and final reports once the study completes.
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Can patients enroll in the trial right now?
As of the last update, enrollment is open. Interested patients should contact the study coordinator via the contact information listed on the trial’s ClinicalTrials.gov entry. Eligibility screening will confirm suitability for the intervention.
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