Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
NCT ID: NCT04672525
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
436 participants
INTERVENTIONAL
2021-11-08
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RIFAMPICIN
Patient with staphylococcal PJI, treated with DAIR strategy, and randomized in the control group will receive rifampicin in association with another antibiotic except rifabutin, as-per recommendations for 12 weeks.
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
RIFABUTIN
Patient with staphylococcal PJI treated with DAIR strategy, and randomized in the experimental group, will receive rifabutin in association with another antibiotic except rifampicin, as-per recommendations for 12 weeks.
Rifabutin
2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Tourcoing Hospital
OTHER
Responsible Party
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Principal Investigators
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Eric SENNEVILLE, Md PhD
Role: PRINCIPAL_INVESTIGATOR
CH TOURCOING
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Benoit BRUNSCHWEILER
Role: primary
Kévin BOUILLER
Role: primary
Fréderic-Antoine DAUCHY
Role: primary
Aurélien DINH
Role: primary
Severine ANSART
Role: primary
Lionel PIROTH
Role: primary
Henry MIGAUD
Role: primary
Anne-Laure BLANC
Role: primary
Tristan FERRY
Role: primary
Johan COURJON
Role: primary
Violaine TOLSMA
Role: primary
Lydie KHATCHATOURIAN
Role: primary
Cédric ARVIEUX
Role: primary
Cécile RONDE-OUSTAU
Role: primary
Eric SENNEVILLE
Role: primary
Louis BERNARD
Role: primary
Other Identifiers
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RIPH_2019_01
Identifier Type: -
Identifier Source: org_study_id
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