drugset / Trial / NCT04672525

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

NCT04672525

Phase 3 Recruiting 436 enrolled Tourcoing Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders. The hypothesis is that rifabutin may be an alternative antibiotic option as efficient as rifampicin for the treatment of staphylococcal PJIs, with a better safety profile. The investigator aim to demonstrate the non-inferiority of rifabutin as compared with rifampicin prescribed in combination treatment for PJIs.

Timeline

Start
2021-11-08
Primary completion
2026-11
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifabutin Small molecule 300 mg
Comparator Rifampin Small molecule 10 mg/kg