VA Drug InteractionCLINDA-RIFAMNCT03267225
Genetic Determinants of Clindamycin/Rifampin Interaction
An observational study of VA Drug Interaction, run by Dr Valerie ZELLER at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VA Drug Interaction
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient treated for a bone or joint infection with a clindamycin/rifampin combination therapy, for at least 10 days
Who may be able to join
- bone or joint infection
- aged ≥ 18 years old
- treatment with clindamycin/rifampin combination therapy > 10 days
Who cannot join
- prescription of another treatment with potential action on CYP450
- pregnant or breast feeding patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the 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
Read the 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
- Conditions
- VA Drug Interaction
- Keywords
- drug interaction, genetic polymorphism
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic polymorphism of PXR, LXRalpha, CYP450 on clindamycin clearance with 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.
Measured: 10 days after onset of clindamycin/rifampin combination therapy
Secondary outcomes (4)
Genetic polymorphism of PXR, LXRalpha, CYP450 on clindamycin clearance before combination therapy with rifampin (clindamycin monotherapy)
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.
Measured: One to four days after onset of clindamycin therapy and before starting rifampin therapy
Genetic polymorphism of PXR, LXRalpha, CYP450 on the increase of CYP 3A4 activity before combination therapy with rifampin
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.
Measured: One to four days after onset of clindamycin therapy and before starting rifampin therapy
Genetic polymorphism of PXR, LXRalpha, CYP450 on the increase of CYP 3A4 activity after 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.
Measured: 10 days after onset of clindamycin/rifampin combination therapy
Difference between expected and observed clindamycine serum concentration after dosage adjustment, in patients after combination therapy with clindamycin and rifampin,.
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 %.
Measured: 10 days after onset of clindamycin/rifampin combination therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study startJan 2016
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VA Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Valerie ZELLER
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Responsible party
- Sponsor-investigator, Dr Valerie ZELLER, Groupe Hospitalier Diaconesses Croix Saint-Simon
- Investigators
- Valérie Zeller, MD, Principal investigator, GH Diaconesses Croix Saint Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267225
- Sponsor's protocol ID
- D-VZR_2015_3
- Acronym
- CLINDA-RIFAM
- Status last verified
- Oct 2022
- First submitted
- 9 Sep 2016
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Genetic Determinants of Clindamycin/Rifampin Interaction
- ClinicalTrials.gov ID
- NCT03267225
- Acronym / sponsor ID
- CLINDA-RIFAM / D-VZR_2015_3
- Conditions
- VA Drug Interaction
- Keywords
- drug interaction, genetic polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Dr Valerie ZELLERUniversity, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Study start
- Jan 2016 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient treated for a bone or joint infection with a clindamycin/rifampin combination therapy, for at least 10 days
Key inclusion criteria (3 listed)
- bone or joint infection
- aged ≥ 18 years old
- treatment with clindamycin/rifampin combination therapy > 10 days
Key exclusion criteria (2 listed)
- prescription of another treatment with potential action on CYP450
- pregnant or breast feeding patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Zeller, MD principal investigator
GH Diaconesses Croix Saint Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VA Drug Interaction, run by Dr Valerie ZELLER at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.