Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020, France
Completed
NCT Number: NCT03267225
Genetic Determinants of Clindamycin/Rifampin Interaction
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
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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.
-
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.
-
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.
-
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 %.
Sponsors and collaborators
Lead sponsor
Dr Valerie ZELLER
Other
Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Registry information
Official study title
Study on the Genetic Determinants of Clindamycin/Rifampin Interaction
Acronym: CLINDA-RIFAM
Important dates
- Study start
- 2016
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Aug 30, 2017
- Registry last updated
- Oct 25, 2022
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.