Effect of Inflammation on Voriconazole Concentration
InflammationFungal InfectionVoriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between the efficacy and safety of voriconazole and voriconazole trough concentrations. There are several factors that could influence voriconazole concentrations. Inflammation could be one of these factors. In a retrospective study was observed that reduced metabolism of voriconazole was related to inflammation in patients with severe infections. Reduced metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an algorithm to guide dosing of voriconazole during severe inflammation and to develop a multiple linear regression model to describe the contribution of CRP concentrations to the variability in voriconazole levels and metabolic ratio.
Bioequivalence Study for Terbinafine 250 mg
MycosesThe objective of this study was to confirm if two formulations of terbinafine (tablets) are bioequivalent. Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product Lamisil® 250 mg (Novartis). One tablet was the single dosage. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 30 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)
Fungal InfectionsThis study will examine the safety and efficacy of posaconazole in general use in Korea. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Effect of Weight and/or Obesity on Caspofungin Drug Concentrations
ObesityFungal InfectionThis study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.
Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Systemic MycosisTo collect the efficacy and safety informations of voriconazole related to their appropriate use in daily practice.
ImPACt on Invasive Fungal Infections by Immune Checkpoint Inhibition
Invasive Fungal InfectionsThis observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (IFI) against healthy controls.
Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients...
Invasive Fungal InfectionsThe aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric patients in Asia/Oceania.
Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization...
CandidiasisVulvovaginal6 moreNon-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study
Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients...
Acute LeukemiaInvasive Fungal InfectionThe aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Bacterial Infections and MycosesLiver DiseaseThe objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.