Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

N/ACompletedNCT02782078

Assistance Publique - Hôpitaux de Paris20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Staphylococcal Infections

Interventions

Clindamycin and rifampicin dosagesBIOLOGICAL

blood samples for clindamycin and rifampicin dosages (for each patient)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Médecine Interne - Hôpital Bichat Claude Bernard

Paris, France

Outcomes

Primary Outcomes

clindamycin AUC (area under curve) at steady state and after rifampicin introduction

this AUC of clindamycin will be compared to AUC before rifampicin introduction, at day 0

Time frame: clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction

Secondary Outcomes

rifampicin auto induction

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

Time frame: AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction)

clinical outcome

resolution of symptoms first described (pain, swelling, fever…) with specific scale

Time frame: at day 4, day 14, day 28 (or day 60 if osteosynthesis)

biological outcome

resolution of inflammatory syndrome (measure of C reactive protein) and hyperleucocytosis (WBC)

Time frame: at day 4, day 14, day 28 (or day 60 if osteosynthesis)

side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0

skin lesion, digestive symptoms, clostridium infection, liver cytolysis, hematological disorders (leucopenia, hemolytic anemia, thrombopenia)…

Time frame: at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis)

Data from ClinicalTrials.gov

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