Staphylococcal Infections
Conditions
Keywords
osteoarticular infection, rifampicin, clindamycin, enzymatic induction, antibiotherapy resistance
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.
Interventions
BIOLOGICALClindamycin and rifampicin dosages
blood samples for clindamycin and rifampicin dosages (for each patient)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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)… |
Countries
France
Outcome results
None listed