Actively Recruiting
Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
Led by Tourcoing Hospital · Updated on 2022-05-10
436
Participants Needed
30
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hip or knee prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prosthesis (DAIR strategy)
- Infection with Staphylococcus aureus or coagulase-negative staphylococci
- Microorganisms susceptible to rifampicin and at least one other suitable antibiotic for PJI treatment
- Age 18 years or older
- At least 2 days of appropriate empirical antibiotic agents before randomization
- Signed informed consent
- Patient has rights to French social insurance
- Women of childbearing potential must use effective contraception except oestroprogestative-based methods
You will not qualify if you...
- Suspected reduced absorption of oral treatment due to abdominal disorders
- Polymicrobial infection involving non-staphylococcal rifampicin-susceptible species
- Known or suspected allergy to rifabutin and/or rifampicin
- Diagnosis of endocarditis associated with PJI
- Renal transplant or chronic kidney disease with eGFR less than 30 ml/min/1.73m²
- Other solid organ transplant
- Liver cirrhosis, Child-Pugh score C
- Any other infection requiring prolonged intravenous antibiotics
- Use of oestroprogestative-based contraception
- Use of oral anticoagulant drugs
- Any drug interaction contraindicating rifampicin or rifabutin
- Porphyria
- Unable to take oral treatment
- Received rifampicin or rifabutin postoperative antibiotic treatment before randomization
- Pregnancy or lactation
- Under guardianship or judicial protection
- Participation in other interventional research during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
CHU Amiens Picardie
Amiens, France
Not Yet Recruiting
2
CHU Angers
Angers, France
Not Yet Recruiting
3
CHU Besançon
Besançon, France
Actively Recruiting
4
CH de Béthune
Béthune, France
Not Yet Recruiting
5
CHU Bordeaux
Bordeaux, France
Not Yet Recruiting
6
APHP Hôpital Ambroise Paré
Boulogne-Billancourt, France
Not Yet Recruiting
7
CHRU Brest
Brest, France
Actively Recruiting
8
CHU Caen
Caen, France
Actively Recruiting
9
CH Alpes Leman
Contamine-sur-Arve, France
Not Yet Recruiting
10
CHU Dijon Bourgogne
Dijon, France
Not Yet Recruiting
11
CHU Grenoble Alpes
Grenoble, France
Not Yet Recruiting
12
CHRU Lille
Lille, France
Actively Recruiting
13
GHICL Hôpital Saint Vincent de Paul
Lille, France
Not Yet Recruiting
14
CHU de Limoges
Limoges, France
Actively Recruiting
15
GHICL Hôpital Saint Philibert
Lomme, France
Not Yet Recruiting
16
Clinique de la Sauvegarde
Lyon, France
Not Yet Recruiting
17
Hospices Civils de Lyon
Lyon, France
Not Yet Recruiting
18
APHM Hôpital Nord
Marseille, France
Not Yet Recruiting
19
CHU Nice
Nice, France
Not Yet Recruiting
20
CH Annecy Genevois
Pringy, France
Actively Recruiting
21
CH Cornouaille
Quimper, France
Not Yet Recruiting
22
CHU Reims
Reims, France
Not Yet Recruiting
23
CHU de Rennes
Rennes, France
Actively Recruiting
24
CHU Saint Etienne
Saint-Priest-en-Jarez, France
Not Yet Recruiting
25
CHRU Strasbourg
Strasbourg, France
Not Yet Recruiting
26
Hôpital d'instruction des armées Sainte Anne
Toulon, France
Actively Recruiting
27
Clinique Joseph Ducuing
Toulouse, France
Not Yet Recruiting
28
Clinique Médipole Garonne
Toulouse, France
Not Yet Recruiting
29
CH Tourcoing
Tourcoing, France
Actively Recruiting
30
CHRU Tours
Tours, France
Actively Recruiting
Research Team
E
Eric SENNEVILLE, MD PhD
CONTACT
S
Solange TREHOUX
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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