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Study on the Genetic Determinants of Clindamycin/Rifampin Interaction (CLINDA-RIFAM)

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ClinicalTrials.gov Identifier: NCT03267225
Recruitment Status : Unknown
Verified September 2017 by Dr Valerie ZELLER, Groupe Hospitalier Diaconesses Croix Saint-Simon.
Recruitment status was:  Recruiting
First Posted : August 30, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Fondation Ophtalmologique Adolphe de Rothschild
Information provided by (Responsible Party):
Dr Valerie ZELLER, Groupe Hospitalier Diaconesses Croix Saint-Simon

Brief Summary:

Main objective- To study the influence of the polymorphisms of nuclear receptor proteins pregnane X receptor (PXR), Liver X receptor alpha (LXRα), and Cytochrome P450 (CYP450) on the clindamycin clearance during clindamycin/rifampin combination therapy.

Secondary objectives To study the influence of these polymorphisms on clindamycin clearance, before combination therapy with rifampin (clindamycin monotherapy) To study the influence of these polymorphisms on CYP450 activity before combination therapy with rifampin (clindamycin monotherapy) To study the influence of these polymorphisms on the increase of CYP450 activity after clindamycin/rifampin combination therapy To study the difference between the expected and observed clindamycin serum concentrations after dosage adjustment, in patients with clindamycin dosage adjustment after combination therapy with rifampin


Condition or disease
VA Drug Interaction

Detailed Description:

Eligible patients will be informed on the study during their hospitalisation in the unit for the treatment of bone and joint infection by the medical doctor. If they agree to participate in the study, the following samples will be performed :

  • After at least 24 hours of clindamycin therapy and before combination therapy with rifampin:

    • 1 urine sample (5 mL) for CYP 450 activity phenotyping
    • 1 blood sample (5 mL on ethylenediaminetetraacetic acid (EDTA) tubes) for measuring clindamycin serum concentration and genotyping
  • After ten days of clindamycin-rifampin combination therapy:

    • 1 urine sample (5 mL) for CYP 450 activity phenotyping
    • 1 blood sample (5 mL on EDTA tubes) for measuring clindamycin serum concentration and genotyping

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Study Start Date : January 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions




Primary Outcome Measures :
  1. Genetic polymorphism of PXR, LXRalpha, CYP450 on clindamycin clearance with clindamycin/rifampin combination therapy [ Time Frame: 10 days after onset of clindamycin/rifampin combination therapy ]
    Impact of PXR, LXRα, CYP 450 3A4/A5 polymorphism on clindamycin clearance after combination clindamycin-rifampin therapy will be analyzed by studying the association of these polymorphisms and clindamycin serum concentrations.


Secondary Outcome Measures :
  1. Genetic polymorphism of PXR, LXRalpha, CYP450 on clindamycin clearance before combination therapy with rifampin (clindamycin monotherapy) [ Time Frame: One to four days after onset of clindamycin therapy and before starting rifampin therapy ]
    Impact of PXR, LXRα, CYP 450 3A4/A5 polymorphism on clindamycin clearance before rifampin therapy will be analyzed by studying the association of these polymorphisms and clindamycin serum concentrations.

  2. Genetic polymorphism of PXR, LXRalpha, CYP450 on the increase of CYP 3A4 activity before combination therapy with rifampin [ Time Frame: One to four days after onset of clindamycin therapy and before starting rifampin therapy ]
    Impact of PXR, LXRα, CYP 450 3A4/A5 polymorphism on CYP 450 3A activity before combination therapy with rifampin will be analyzed by studying the association of these polymorphisms and clindamycin serum concentrations.

  3. Genetic polymorphism of PXR, LXRalpha, CYP450 on the increase of CYP 3A4 activity after clindamycin/rifampin combination therapy [ Time Frame: 10 days after onset of clindamycin/rifampin combination therapy ]
    Impact of PXR, LXRα, CYP 450 3A4/A5 polymorphism on CYP 450 3A activity after combination with rifampin therapy will be analyzed by studying the association of these polymorphisms and clindamycin serum concentrations.

  4. Difference between expected and observed clindamycine serum concentration after dosage adjustment, in patients after combination therapy with clindamycin and rifampin,. [ Time Frame: 10 days after onset of clindamycin/rifampin combination therapy ]
    The gap between the predicted and observed clindamycin serum concentrations will be quantified by MPE (Mean Prediction Errors) and RMSE (Root Mean Square Prediction Errors). Dosage adjustment will be considered predictive of the concentration if MPE and RMSE are < 20 %.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient treated for a bone or joint infection with a clindamycin/rifampin combination therapy, for at least 10 days
Criteria

Inclusion Criteria:

  • bone or joint infection
  • aged ≥ 18 years old
  • treatment with clindamycin/rifampin combination therapy > 10 days

Exclusion Criteria:

  • prescription of another treatment with potential action on CYP450
  • pregnant or breast feeding patient

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): NCT03267225


Contacts
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Contact: Valérie ZELLER, MD 0144641780 vzeller@hopital-dcss.org
Contact: Laurence SALOMON, MD, PhD 0148036431 lsalomon@for.paris

Locations
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France
Groupe Hospitalier Diaconesses Croix Saint Simon Recruiting
Paris, France, 75020
Sponsors and Collaborators
Dr Valerie ZELLER
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Valérie Zeller, MD GH Diaconesses Croix Saint Simon

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Responsible Party: Dr Valerie ZELLER, MD, principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier: NCT03267225     History of Changes
Other Study ID Numbers: D-VZR_2015_3
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Valerie ZELLER, Groupe Hospitalier Diaconesses Croix Saint-Simon:
drug interaction
genetic polymorphism