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

Primary Purpose

Staphylococcal Infections

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clindamycin and rifampicin dosages
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Infections focused on measuring osteoarticular infection, rifampicin, clindamycin, enzymatic induction, antibiotherapy resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Médecine Interne - Hôpital Bichat Claude Bernard

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clindamycin and rifampicin dosages

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
clinical outcome
resolution of symptoms first described (pain, swelling, fever…) with specific scale
biological outcome
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
skin lesion, digestive symptoms, clostridium infection, liver cytolysis, hematological disorders (leucopenia, hemolytic anemia, thrombopenia)…

Full Information

First Posted
May 2, 2016
Last Updated
March 26, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02782078
Brief Title
Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
Acronym
DALARI
Official Title
Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
January 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections
Keywords
osteoarticular infection, rifampicin, clindamycin, enzymatic induction, antibiotherapy resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clindamycin and rifampicin dosages
Arm Type
Other
Arm Description
blood samples for clindamycin and rifampicin dosages (for each patient)
Intervention Type
Biological
Intervention Name(s)
Clindamycin and rifampicin dosages
Intervention Description
blood samples for clindamycin and rifampicin dosages (for each patient)
Primary Outcome Measure Information:
Title
clindamycin AUC (area under curve) at steady state and after rifampicin introduction
Description
this AUC of clindamycin will be compared to AUC before rifampicin introduction, at day 0
Time Frame
clindamycin AUC will be evaluated after rifampicin interaction, so at day 14 of introduction
Secondary Outcome Measure Information:
Title
rifampicin auto induction
Description
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
Time Frame
AUC of rifampicin at day 4 (before autoinduction ant at steady state) and day 14 (after autoinduction)
Title
clinical outcome
Description
resolution of symptoms first described (pain, swelling, fever…) with specific scale
Time Frame
at day 4, day 14, day 28 (or day 60 if osteosynthesis)
Title
biological outcome
Description
resolution of inflammatory syndrome (measure of C reactive protein) and hyperleucocytosis (WBC)
Time Frame
at day 4, day 14, day 28 (or day 60 if osteosynthesis)
Title
side effects and toxicity: number of participants with treatment related adverse events as assessed by CTCAE v4.0
Description
skin lesion, digestive symptoms, clostridium infection, liver cytolysis, hematological disorders (leucopenia, hemolytic anemia, thrombopenia)…
Time Frame
at day 2, day 4, day 14, day 28 (or day 60 if osteosynthesis)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiphaine Goulenok, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Interne - Hôpital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

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