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Completed

NCT Number: NCT02782078

Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

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

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Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Interne - Hôpital Bichat Claude Bernard

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clindamycin and rifampicin dosages

Biological

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

Primary outcomes

  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 outcomes

  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)…

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: DALARI

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 25, 2016
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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