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

Dr Valerie ZELLER

Status

Completed

Conditions

VA Drug Interaction

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT03267225

D-VZR_2015_3

Details and patient eligibility

About

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

Full 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