Trials / Withdrawn
WithdrawnNCT03554239
Impact of Genotyping P450 2C19 on Hospitalization Period
Impact of Genotyping P450 2C19 on Hospitalization Period When Voriconazole Treatment is Started
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University Hospital, Toulouse · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Monocentric study with the objective to evaluate the impact of genotyping CYP2C19 on the hospitalization period. The genotyping will permit to adapt at best the Voriconazole posology.
Detailed description
The main objective of this multi-center study is to evaluate the impact of dose adjustment of Voriconazole after CYP2C19 genotyping at the start of treatment, on the length of hospital stay. Thus, a new strategy will be proposed as part of this project and will be compared to the reference strategy: The New strategy: genotyping of CYP2C19 in any patient receiving treatment with Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase of the dosage of Voriconazole in high-speed metabolisers or use of another antifungal, decreased dosage in poor metabolisers). The Reference strategy: pharmacological therapeutic monitoring of Voriconazole allowing an adaptation of the Voriconazole dosage based on the residual concentration measured once steady state has been reached (5 elimination half-lives). Multicenter, randomized study comparing two strategies of Voriconazole adaptation according to whether or not genotyping of CYP2C19 is performed as soon as Voriconazole is started. Thus, the new strategy tested in this project and compared to the reference strategy (adaptation of Voriconazole dosage depending on the residual concentration), will be a genotyping of CYP2C19 in any patient receiving a treatment based on Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase in the dosage of Voriconazole or use of another antifungal agent in ultra-rapid metabolisers, decrease in dosage in poor metabolisers).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | genotyping | Blood sample |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2017-07-01
- Completion
- 2017-12-01
- First posted
- 2018-06-13
- Last updated
- 2018-12-20
Source: ClinicalTrials.gov record NCT03554239. Inclusion in this directory is not an endorsement.