Genetic Determinants of Clindamycin/Rifampin Interaction

NCT ID: NCT03267225

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-04-15

Brief Summary

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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

Detailed Description

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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

Conditions

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VA Drug Interaction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role collaborator

Dr Valerie ZELLER

OTHER

Sponsor Role lead

Responsible Party

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Dr Valerie ZELLER

MD, principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Valérie Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

GH Diaconesses Croix Saint Simon

Locations

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Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, , France

Site Status

Countries

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France

Other Identifiers

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D-VZR_2015_3

Identifier Type: -

Identifier Source: org_study_id

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