Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

Staphylococcal Infections Clinical Trial

— DALARI  

Official title:

Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782078
• Other study ID #: P140318 / AOR14027
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: January 3, 2019

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 3, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Staphylococcal Infections

Intervention

Biological:
• Clindamycin and rifampicin dosages
blood samples for clindamycin and rifampicin dosages (for each patient)

Locations

Country	Name	City	State
France	Service de Médecine Interne - Hôpital Bichat Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction)
Secondary	clinical outcome	resolution of symptoms first described (pain, swelling, fever…) with specific scale	at day 4, day 14, day 28 (or day 60 if osteosynthesis)
Secondary	biological outcome	resolution of inflammatory syndrome (measure of C reactive protein) and hyperleucocytosis (WBC)	at day 4, day 14, day 28 (or day 60 if osteosynthesis)
Secondary	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)…	at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis)