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RECRUITING
NCT04672525
PHASE3

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

Sponsor: Tourcoing Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

436

Start Date

2021-11-08

Completion Date

2027-06

Last Updated

2022-05-10

Healthy Volunteers

No

Interventions

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

Locations (30)

CHU Amiens Picardie

Amiens, France

CHU Angers

Angers, France

CHU Besançon

Besançon, France

CH de Béthune

Béthune, France

CHU Bordeaux

Bordeaux, France

APHP Hôpital Ambroise Paré

Boulogne-Billancourt, France

CHRU Brest

Brest, France

CHU Caen

Caen, France

CH Alpes Leman

Contamine-sur-Arve, France

CHU Dijon Bourgogne

Dijon, France

CHU Grenoble Alpes

Grenoble, France

CHRU Lille

Lille, France

GHICL Hôpital Saint Vincent de Paul

Lille, France

CHU de Limoges

Limoges, France

GHICL Hôpital Saint Philibert

Lomme, France

Clinique de la Sauvegarde

Lyon, France

Hospices Civils de Lyon

Lyon, France

APHM Hôpital Nord

Marseille, France

CHU Nice

Nice, France

CH Annecy Genevois

Pringy, France

CH Cornouaille

Quimper, France

CHU Reims

Reims, France

CHU de Rennes

Rennes, France

CHU Saint Etienne

Saint-Priest-en-Jarez, France

CHRU Strasbourg

Strasbourg, France

Hôpital d'instruction des armées Sainte Anne

Toulon, France

Clinique Joseph Ducuing

Toulouse, France

Clinique Médipole Garonne

Toulouse, France

CH Tourcoing

Tourcoing, France

CHRU Tours

Tours, France