Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

NCT ID: NCT02782078

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-06
• Study Completion Date: 2019-01-03

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.

Conditions

Staphylococcal Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clindamycin and rifampicin dosages

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

Group Type: OTHER

Clindamycin and rifampicin dosages

Intervention Type: BIOLOGICAL

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

Interventions

Clindamycin and rifampicin dosages

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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiphaine Goulenok, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de Médecine Interne - Hôpital Bichat Claude Bernard

Paris, , France

Countries

France

Other Identifiers

P140318 / AOR14027

Identifier Type: -

Identifier Source: org_study_id