Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
ConditionProsthetic Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTourcoing Hospital
About this trial
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 criteria
Qualifiers
Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy)
Staphylococcus aureus
Coagulase-negative staphylococci
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.
Disqualifiers
Suspicion of reduce absorption of oral treatment due to abdominal disorder Known or suspected malabsorption (imperfect absorption of food material by the small intestine)
Polymicrobial infection due to other than staphylococcus species susceptible to rifampicin
Known or suspected allergy to rifabutin and/or rifampicin
Diagnosis of endocarditis associated to PJI
Trial design
Treatments tested in this trial
- Rifabutin
- Rifampicin
Treatment groups
436 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov