drugset / Trial / NCT05069974

Alternative Antibiotics for Syphilis

NCT05069974 ↗

Phase 3 Completed 224 enrolled Fight AIDS and Infectious Diseases Foundation
RandomizedParallel-groupSingle-blindTreatment

Summary

The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG), for early syphilis in humans. The overarching idea of the work proposed herein is to investigate the use of LZD to treat syphilis, conducting a randomized controlled clinical trial to evaluate this new indication of a known antibacterial agent.

Timeline

Start
2021-10-14
Primary completion
2026-04-15
Completion
2026-04-15

Outcome

Missed primary endpoint

paper treatment difference -29·6, 95% CI -50·5 to -8·8), which did not meet the non-inferiority criterion. PMID 38211601 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benzathine Penicillin G Unknown 2.4e+06 iu Intramuscular
Subject Linezolid Other / unclassified 600 mg Oral