Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

NCT02782078 | Completed DMC

• 1 other identifier: P140318 / AOR14027
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Staphylococcal Infections

Keywords

osteoarticular infection; rifampicin; clindamycin; enzymatic induction; antibiotherapy resistance

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• rifampicin auto induction

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

• clinical outcome

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

• biological outcome

  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

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

Study Arms (1)

Clindamycin and rifampicin dosages

OTHER

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

Biological: Clindamycin and rifampicin dosages

Interventions

Clindamycin and rifampicin dosages BIOLOGICAL

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

Clindamycin and rifampicin dosages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• participation to another study modifying antibiotic treatment administration

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Interne - Hôpital Bichat Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Tiphaine Goulenok, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 25, 2016
• Study Start: March 6, 2017
• Primary Completion: December 12, 2018
• Study Completion: January 3, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)