Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

Not Applicable

Completed

• Conditions: Staphylococcal Infections
• Interventions: Biological: Clindamycin and rifampicin dosages

• Registration Number: NCT02782078
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin

Detailed Description

It could suggest modification of recommended doses or incitement to antibiotic dosage. Thus, theses antibiotics, if association is allowed, could limit fluoroquinolones prescription and avoid some antibiotic resistance.

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Study Start: 2017-03-06
• Primary Completion: 2018-12-12
• Study Completion: 2019-01-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients ≥18 years of age
• osteoarticular infection
• staphylococcus detected in bacteriological sampling
• sensibility to rifampicin, erythromycin and clindamycin
• active intravenous antibiotherapy against staphylococcus detected in bacteriological sampling

Exclusion Criteria

• septic shock or severe initial sepsis
• osteoarticular infection with other microorganism than staphylococcus
• contraindication to clindamycin or rifampicin including case of hypersensibility to one of these two antibiotics
• pre-existing renal insufficiency or severe renal insufficiency (creatinine clearance <30 ml/min)
• serious cognitive disorders
• patient under guardianship, trusteeship or non affiliated to social security or CMU (beneficiary or assignee)
• refusal to take part in the study and to sign the consent form
• pregnancy
• lactation
• administration of clindamycin or rifampicin within the month before inclusion
• treatment with enzymatic inductor or inhibitor within the month before inclusion
• participation to another study modifying antibiotic treatment administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clindamycin and rifampicin dosages	Clindamycin and rifampicin dosages	blood samples for clindamycin and rifampicin dosages (for each patient)

Primary Outcome Measures

Name	Time	Method
clindamycin AUC (area under curve) at steady state and after rifampicin introduction	clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction	this AUC of clindamycin will be compared to AUC before rifampicin introduction, at day 0

Secondary Outcome Measures

Name	Time	Method
biological outcome	at day 4, day 14, day 28 (or day 60 if osteosynthesis)	resolution of inflammatory syndrome (measure of C reactive protein) and hyperleucocytosis (WBC)
side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0	at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis)	skin lesion, digestive symptoms, clostridium infection, liver cytolysis, hematological disorders (leucopenia, hemolytic anemia, thrombopenia)...
clinical outcome	at day 4, day 14, day 28 (or day 60 if osteosynthesis)	resolution of symptoms first described (pain, swelling, fever...) with specific scale
rifampicin auto induction	AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction)	rifampicin autoinduction will be studied with rifampicin AUC, according time, for each patient, at day 4 and day 14. Comparison of AUC with student's test

Trial Locations

Locations (1)

Service de Médecine Interne - Hôpital Bichat Claude Bernard; 🇫🇷 Paris, France