EVRIOS : Comparative Evaluation of Low Versus High Doses of Rifampicin

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Rifampicin is an antibiotic usually required to treat susceptible Staphylococcus spp. osteo-articular infections, most frequently in association with a fluoroquinolone when the strain is susceptible to both agents. It is the reference treatment for orthopedic infections with implanted material.

For tuberculosis treatment the dosage of 10 mg/kg/j is usually prescribed, while in the treatment of Staphylococcus spp. infections the highest dosage of 20 mg/kg/j is proposed by French experts' recommendations from 2009.

However, there is little evidence in the literature, which could set out arguments to choose the best dosage of rifampicin, which may vary from 5 to 20 mg/kg.

The issue with rifampicin is side effects, in particular with long-term treatment. Many side effects may occur in 10 to 20% of patients and sometimes leads to dosage reduction or treatment interruption.

In the literature, there is little evidence that higher rifampicin dosage is associated with higher frequency of adverse effects. Depending on the nature of the toxicity, one could say that hypersensitivity could be independent from dosage, when digestive disorders may be related. Plasmatic concentrations studies have not given strong arguments to link higher rifampicin dosages with side effects occurrence rates. After oral absorption, plasmatic peak occurs after two to five hours and varies among individuals but also in the same patient overtime. This particular pharmacokinetic profile could explain discrepancy in adverse events (AEs) frequencies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Anti-Bacterial Agents; Fluoroquinolones; Rifampin

Criteria

Inclusion Criteria:

• Adult patients (over 18 years old) who gave their signed inform consent,

• Who present an osteo-articular infection with susceptible Staphylococcus spp.,

• To whom a rifampicin based regimen is prescribed, in association with another antibiotic, for at least 14 days,

• Patients covered by Health Insurance.

Exclusion Criteria:

• Patients weighing less than 45 kg or more than 150 kg,

• Patients with active TB (whatever its localization),

• Patients needing the imperative use of a treatment presenting a contraindication for concomitant use in the SPC of Rimactan®

• Patients with a known and documented rifampicin allergy or severe rifampicin intolerance,

• Patients with galactose intolerance, total lactase deficiency or glucose or galactose malabsorption syndrome, or any other contraindication to the administration of Rimactan® listed in the SPC for Rimactan®

• Pregnant or breastfeeding woman,

• Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty,

• Patients participating in another interventional clinical trial (biomedical trial or standard care clinical trial).