rifabutin
Drug2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment
NCT Number: NCT04672525
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
CHU Amiens Picardie, Amiens, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment
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
Time frame: At one year
Treatment failure defined as one of following events:
Time frame: At the end of 12 weeks duration of antibiotic treatment planned
Proportion of patient which are free from SAEs occurrence, as defined by:
-Patients who completed the entire 12 weeks duration of antibiotic treatment planned initially and; xWho did not experience grade 3-4 adverse events, including death, regardless of the link with antibiotic therapy; xWho did not experience adverse events which led to either to:
Time frame: At the end of 12 weeks duration of antibiotic treatment planned
Number and rate of patients in each arm who experiences:
Time frame: At the end of 12 weeks duration of antibiotic treatment planned
Early termination rate will be measured in each arm, as the number of patients having stopped rifampicin or rifabutin before the planned 12 weeks period over the total number of patients enrolled in the studied arm.
Time frame: At the end of 12 weeks duration of antibiotic treatment planned
Adherence rate to medication will be measured as the number of days on which all doses were missed over the number of days of planned antibiotic therapy. Patients enrolled in the study will have to fill their pill count in a daily notebook.
Time frame: At the end of the study follow up, an average of 24 months
Quality of life, as evaluated by the use EQ 5D 3L auto-questionnaire as used in previous randomized clinical trial on bone and joint infection
Time frame: At the end of the study follow up, an average of 24 months
Oxford Scores as used in previous randomized clinical trial on bone and joint infection
Time frame: At the end of the study follow up, an average of 24 months
Long term efficacy: treatment failure, as defined for primary outcome, at 24 months
Contact information is provided by the study sponsor or research team.
Eric SENNEVILLE, MD PhD
CONTACT
Solange TREHOUX
CONTACT
Tourcoing Hospital
Other
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
Acronym: RIFAMAB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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