NCT04672525

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

Rifabutin Versus Rifampicin for Treatment of Staphylococcal Prosthetic Joint Infection Treated With Debridement, Antibiotics and Implant Retention (DAIR Strategy): a Multicenter Randomized, Open-label, Non-inferiority Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (estimated)
• Sponsor: Tourcoing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prosthetic Infection

Interventions

Type	Name	Description
DRUG	Rifabutin	2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment
DRUG	Rifampicin	10 mg/kg per day (range 600 mg to 1,200 mg) rifampicin tablet in 1 daily dose for 12 weeks with a companion treatment

Timeline

• Start date: 2021-11-08
• Primary completion: 2026-11-01
• Completion: 2027-06-01
• First posted: 2020-12-17
• Last updated: 2022-05-10

Locations

30 sites across 1 country: France