Informations générales (source: ClinicalTrials.gov)
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 (RIFAMAB)
Interventional
Phase 3
Tourcoing Hospital (Voir sur ClinicalTrials)
novembre 2021
juin 2027
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH Alpes Leman - Contamine-sur-Arve - France | Contact (sur clinicalTrials) | ||||
| CH Annecy Genevois - Pringy - France | Violaine TOLSMA | Contact (sur clinicalTrials) | |||
| CH Cornouaille - Quimper - France | Lydie KHATCHATOURIAN | Contact (sur clinicalTrials) | |||
| CH de Béthune - Béthune - France | Contact (sur clinicalTrials) | ||||
| CHU de Rennes - Rennes - France | Cédric ARVIEUX | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM Hôpital Nord - Marseille - France | Contact (sur clinicalTrials) | ||||
| APHP Hôpital Ambroise Paré - Boulogne-Billancourt - France | Aurélien DINH | Contact (sur clinicalTrials) | |||
| CH Tourcoing - Tourcoing - France | Eric SENNEVILLE | Contact (sur clinicalTrials) | |||
| CHRU Brest - Brest - France | Severine ANSART | Contact (sur clinicalTrials) | |||
| CHRU Lille - Lille - France | Henry MIGAUD | Contact (sur clinicalTrials) | |||
| CHRU Strasbourg - Strasbourg - France | Cécile RONDE-OUSTAU | Contact (sur clinicalTrials) | |||
| CHRU Tours - Tours - France | Louis BERNARD | Contact (sur clinicalTrials) | |||
| CHU Amiens Picardie - Amiens - France | Benoit BRUNSCHWEILER | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU Besançon - Besançon - France | Kévin BOUILLER | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Fréderic-Antoine DAUCHY | Contact (sur clinicalTrials) | |||
| CHU Caen - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Limoges - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon Bourgogne - Dijon - France | Lionel PIROTH | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHU Nice - Nice - France | Johan COURJON | Contact (sur clinicalTrials) | |||
| CHU Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU Saint Etienne - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| Clinique de la Sauvegarde - Lyon - France | Anne-Laure BLANC | Contact (sur clinicalTrials) | |||
| Clinique Joseph Ducuing - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Clinique Médipole Garonne - Toulouse - France | Contact (sur clinicalTrials) | ||||
| GHICL Hôpital Saint Philibert - Lomme - France | Contact (sur clinicalTrials) | ||||
| GHICL Hôpital Saint Vincent de Paul - Lille - France | Contact (sur clinicalTrials) | ||||
| Hôpital d'instruction des armées Sainte Anne - Toulon - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Lyon - France | Tristan FERRY | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy
initiation and retention of prothesis (DAIR strategy)
2. Infected with at least one of the following microorganisms:
1. Staphylococcus aureus
2. Coagulase-negative staphylococci
3. Microorganisms susceptible to rifampicin and at least one other antibiotic suitable
for the treatment of PJI (e.g., penicillin, fluoroquinolone, (doxy/mino)cycline,
oxazolidinone, cotrimoxazole, daptomycin, glycopeptide, macrolide, fusidic acid),
regardless of sensitivity to methicillin.
4. Age ≥ 18 years
5. At least 2 days of appropriate (i.e., covering pathogen(s) identified in the
intraoperative samples) empirical agents are needed. Pre-randomization antimicrobial
therapy could be: flucloxacillin, oxacillin, vancomycin, daptomycin. β-lactam plus
β-lactamase-inhibitors (e.g. ampicillin+sulbactam, piperacillin+tazobactam),
cephalosporins (except ceftazidime), carbapenems, teicoplanin, ceftaroline,
ceftobiprole.
6. Signed Inform consent
7. Patient having the rights to French social insurance
8. For women of childbearing potential i.e. fertile, following menarche and until
becoming post-menopausal unless permanently sterile and excluding
oestroprogestative-based contraception, any effective contraceptive: vasectomy (for
men), intrauterine device copper, feminine sterilization, condom, sexual abstinence
is required. A postmenopausal state is defined as no menses for 12 months without an
alternative medical cause
1. Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy
initiation and retention of prothesis (DAIR strategy)
2. Infected with at least one of the following microorganisms:
1. Staphylococcus aureus
2. Coagulase-negative staphylococci
3. Microorganisms susceptible to rifampicin and at least one other antibiotic suitable
for the treatment of PJI (e.g., penicillin, fluoroquinolone, (doxy/mino)cycline,
oxazolidinone, cotrimoxazole, daptomycin, glycopeptide, macrolide, fusidic acid),
regardless of sensitivity to methicillin.
4. Age ≥ 18 years
5. At least 2 days of appropriate (i.e., covering pathogen(s) identified in the
intraoperative samples) empirical agents are needed. Pre-randomization antimicrobial
therapy could be: flucloxacillin, oxacillin, vancomycin, daptomycin. β-lactam plus
β-lactamase-inhibitors (e.g. ampicillin+sulbactam, piperacillin+tazobactam),
cephalosporins (except ceftazidime), carbapenems, teicoplanin, ceftaroline,
ceftobiprole.
6. Signed Inform consent
7. Patient having the rights to French social insurance
8. For women of childbearing potential i.e. fertile, following menarche and until
becoming post-menopausal unless permanently sterile and excluding
oestroprogestative-based contraception, any effective contraceptive: vasectomy (for
men), intrauterine device copper, feminine sterilization, condom, sexual abstinence
is required. A postmenopausal state is defined as no menses for 12 months without an
alternative medical cause
1. Suspicion of reduce absorption of oral treatment due to abdominal disorder Known or
suspected malabsorption (imperfect absorption of food material by the small
intestine)
2. Polymicrobial infection due to other than staphylococcus species susceptible to
rifampicin
3. Known or suspected allergy to rifabutin and/or rifampicin
4. Diagnosis of endocarditis associated to PJI
5. Renal transplant or Chronic kidney disease with an eGFR of less than 30ml/min/1.73m²
6. Other Solid Organ Transplant
7. Liver cirrhosis, Child-Pugh score C
8. Any other concomitant infection which required a prolonged course of intravenous
antibiotic therapy
9. Oestroprogestative-based contraception
10. Oral anticoagulant drugs
11. Other drug-drug interaction that contraindicated rifampicin or rifabutin
12. Porphyria
13. Unable to take oral treatment
14. Receive empirical postoperative antibiotic treatment by rifampicin or rifabutin
prior to randomization
15. Pregnancy or lactating women
16. Curator or guardianship or patient placed under judicial protection
17. Participation in other interventional research during the study