A Phase 3 interventional study of Rifabutin and Rifampicin in Prosthetic Infection, sponsored by Tourcoing Hospital. Recruiting at 30 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by Tourcoing Hospital · Phase 3, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 436 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Tourcoing Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infected with at least one of the following microorganisms:
Exclusion Criteria:
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.
Drug: Rifampicin
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.
Drug: Rifabutin
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
Treatment failure
Treatment failure defined as one of following events: * The need for any further surgical procedure - i.e. implants removal, implants exchange or amputation; * And/or PJI related death; * And/or use of suppressive antibiotic therapy that was not planned before randomization
Time frame: At one year
Occurrence of serious adverse events (SAEs), including death (i.e. all cause)
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: * Reduce the dosage or split the treatment to two take/day; * Or stop any component of the antibiotic treatment.
Time frame: At the end of 12 weeks duration of antibiotic treatment planned
Occurrence of any adverse event that could be related to rifampicin or rifabutin
Number and rate of patients in each arm who experiences: * Liver cytolysis (\>=2N for ALT AND/OR AST) * Acute Kidney failure as defined by serum creatinine increase in KDIGO * Digestive symptoms, including diarrhea * Who required a modification of antibiotic dosage during the 12 weeks' period of antibiotic treatment * Uveitis/ophthalmologic disorder * Neurological disorder
Time frame: At the end of 12 weeks duration of antibiotic treatment planned
Proportion of patients from each arm who will complete the 12-week duration of rifampicin/rifabutin treatment, early termination of the planned 12 weeks' period of antibiotics
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 to antibiotics regimen
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 12 weeks duration of antibiotic treatment planned
Quality of life, as evaluated by EQ 5D 3L questionnaire
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
Functional prognosis using Oxford questionnaire evolution according to location of PJI
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 of rifampicin and rifabutin treatment
Long term efficacy: treatment failure, as defined for primary outcome, at 24 months
Time frame: At the end of the study follow up, an average of 24 months
Plan to share: No
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Tourcoing Hospital