Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
Condition(s) studied
Investigational drug(s) / intervention(s)
Rifabutin: 2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment
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
Study 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.
Eligibility
Primary outcome measure(s)
- Treatment failure — At one year
Treatment failure defined as one of following events: * The need for any further surgical procedure - i.e. implants removal, implants exchange or amputation; * And/or PJI related death; * And/or use of suppressive antibiotic therapy that was not planned before randomization
Trial sites (30)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Amiens Picardie | Amiens | France | Not Yet Recruiting |
| CHU Angers | Angers | France | Not Yet Recruiting |
| CHU Besançon | Besançon | France | Recruiting |
| CH de Béthune | Béthune | France | Not Yet Recruiting |
| CHU Bordeaux | Bordeaux | France | Not Yet Recruiting |
| APHP Hôpital Ambroise Paré | Boulogne-Billancourt | France | Not Yet Recruiting |
| CHRU Brest | Brest | France | Recruiting |
| CHU Caen | Caen | France | Recruiting |
| CH Alpes Leman | Contamine-sur-Arve | France | Not Yet Recruiting |
| CHU Dijon Bourgogne | Dijon | France | Not Yet Recruiting |
| CHU Grenoble Alpes | Grenoble | France | Not Yet Recruiting |
| CHRU Lille | Lille | France | Recruiting |
| GHICL Hôpital Saint Vincent de Paul | Lille | France | Not Yet Recruiting |
| CHU de Limoges | Limoges | France | Recruiting |
| GHICL Hôpital Saint Philibert | Lomme | France | Not Yet Recruiting |
| Clinique de la Sauvegarde | Lyon | France | Not Yet Recruiting |
| Hospices Civils de Lyon | Lyon | France | Not Yet Recruiting |
| APHM Hôpital Nord | Marseille | France | Not Yet Recruiting |
| CHU Nice | Nice | France | Not Yet Recruiting |
| CH Annecy Genevois | Pringy | France | Recruiting |
| CH Cornouaille | Quimper | France | Not Yet Recruiting |
| CHU Reims | Reims | France | Not Yet Recruiting |
| CHU de Rennes | Rennes | France | Recruiting |
| CHU Saint Etienne | Saint-Priest-en-Jarez | France | Not Yet Recruiting |
| CHRU Strasbourg | Strasbourg | France | Not Yet Recruiting |
| Hôpital d'instruction des armées Sainte Anne | Toulon | France | Recruiting |
| Clinique Joseph Ducuing | Toulouse | France | Not Yet Recruiting |
| Clinique Médipole Garonne | Toulouse | France | Not Yet Recruiting |
| CH Tourcoing | Tourcoing | France | Recruiting |
| CHRU Tours | Tours | France | Recruiting |
More Tourcoing Hospital trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04672525 on ClinicalTrials.gov ↗ ← All trials in France