Clinical trial NCT02782078: Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
Official title: Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Staphylococcal Infections
Keywords: osteoarticular infection
rifampicin
clindamycin
enzymatic induction
antibiotherapy resistance
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: clindamycin AUC (area under curve) at steady state and after rifampicin introduction
timeFrame: clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction
Secondary outcomes:
measure: rifampicin auto induction
timeFrame: AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction)
measure: clinical outcome
timeFrame: at day 4, day 14, day 28 (or day 60 if osteosynthesis)
measure: biological outcome
timeFrame: at day 4, day 14, day 28 (or day 60 if osteosynthesis)
measure: side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0
timeFrame: at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis)
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Tiphaine Goulenok, MD
role: PRINCIPAL_INVESTIGATOR
References: