Rifabutin versus rifampicin, staphylococcal prosthetic joint infection, multicenter randomized, open-label, non-inferiority trial

Phase 1

• Conditions: Adult with an staphylococcal prosthetic joint infection treated with debridement, antibiotics and implant retention (DAIR strategy); MedDRA version: 20.0Level: LLTClassification code 10065011Term: Prosthesis related infectionSystem Organ Class: 100000004862; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2020-000471-20-FR
• Lead Sponsor: CH Tourcoing

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-14
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

1.Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy)
2.Microbiologically documented infection corresponds to the isolation of staphylococcus aureus or coagulase-negative Staphylococcus aureus from reliable samples: intraoperatively (= 3 during synovectomy-washing), joint puncture or blood culture; the microorganism(s) will be considered pathogenic if identified in = 2 reliable samples.
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.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 218
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 218

Exclusion Criteria

1.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.Ongoing treatment that contraindicates the use of rifampicin or rifabutine
11.Porphyria
12.Unable to take oral treatment
13.Receive empirical postoperative antibiotic treatment by rifampicin or rifabutin prior to randomization
14.Pregnancy or lactating women
15.Curator or guardianship or patient placed under judicial protection
16.Participation in other interventional research during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified