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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

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE March 6, 2017
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02782078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
  • 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
  • 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
  • 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)
  • 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)…
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
Official Title  ICMJE Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Staphylococcal Infections
Intervention  ICMJE Biological: Clindamycin and rifampicin dosages
blood samples for clindamycin and rifampicin dosages (for each patient)
Study Arms  ICMJE Clindamycin and rifampicin dosages
blood samples for clindamycin and rifampicin dosages (for each patient)
Intervention: Biological: Clindamycin and rifampicin dosages
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782078
Other Study ID Numbers  ICMJE P140318 / AOR14027
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tiphaine Goulenok, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP