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Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections (DALARI)

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ClinicalTrials.gov Identifier: NCT02782078
Recruitment Status : Active, not recruiting
First Posted : May 25, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Staphylococcal Infections Biological: Clindamycin and rifampicin dosages Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Clindamycin and rifampicin dosages
blood samples for clindamycin and rifampicin dosages (for each patient)
Biological: Clindamycin and rifampicin dosages
blood samples for clindamycin and rifampicin dosages (for each patient)




Primary Outcome Measures :
  1. clindamycin AUC (area under curve) at steady state and after rifampicin introduction [ Time Frame: 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 Outcome Measures :
  1. rifampicin auto induction [ Time Frame: 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

  2. clinical outcome [ Time Frame: at day 4, day 14, day 28 (or day 60 if osteosynthesis) ]
    resolution of symptoms first described (pain, swelling, fever…) with specific scale

  3. biological outcome [ Time Frame: at day 4, day 14, day 28 (or day 60 if osteosynthesis) ]
    resolution of inflammatory syndrome (measure of C reactive protein) and hyperleucocytosis (WBC)

  4. side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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)…



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782078


Locations
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France
Service de Médecine Interne - Hôpital Bichat Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Tiphaine Goulenok, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02782078     History of Changes
Other Study ID Numbers: P140318 / AOR14027
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
osteoarticular infection
rifampicin
clindamycin
enzymatic induction
antibiotherapy resistance

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifampin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Protein Synthesis Inhibitors