View clinical trials related to Fluconazole.
Filter by:This study is based on the hypothesis that the pharmacokinetics of fluconazole in newborns and children are different from adults. We aim to study the population pharmacokinetics of newborns and children receiving the fluconazole for treatment of infectious diseases. In this study, we will detect fluconazole concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, we also want to correlate use of fluconazole with treatment effectiveness and incidence of adverse effects in newborns and children. This novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in newborns and children. It will also set the foundation for further studies to improve fluconazole therapies for newborns and children.
The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. The investigators will determine fluconazole and free fluconazole concentrations in 16 obese patients and 8 healthy volunteers, who will receive oral and intravenous fluconazole in a semi-simultaneous design. A full pharmacokinetic curve will be obtained until 48 hours after intravenous administration.
Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing countries due to its affordability and feasibility. Nonetheless, the potential drug-drug interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report has demonstrated that fluconazole significantly raises plasma NVP levels and may cause serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for the concurrent use of both drugs in order to avoid the adverse events. A previous study has demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions. There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian populations. We therefore conducted this prospective observational study to compare the trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected patients who did not receive FLU and received FLU in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received NVP-based ART regimens.