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NCT03267225: CLINDA-RIFAM

Study on the Genetic Determinants of Clindamycin/Rifampin Interaction

Completed Last updated 24 October 2022
What this trial tests

trial in VA Drug Interaction in 84 participants. Completed in 15 April 2021.

Timeline
1 January 2016
Primary endpoint
15 April 2021
15 April 2021

Quick facts

Lead sponsorDr Valerie ZELLER
StatusCompleted
Study typeOBSERVATIONAL
Enrollment84
Start date1 January 2016
Primary completion15 April 2021
Estimated completion15 April 2021
Sites1 location across France

Conditions studied

Sponsor

Dr Valerie ZELLER

Who can join

18 and older, any sex, with VA Drug Interaction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03267225.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing