11 results
• To determine the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non myeloablative (NMA)) for…
The primary objective of this study is to evaluate the PK of POS administered orally at three dosage levels to immunocompromised children with expected neutropenia (selected oncology patients, aplastic anemia patients and patients which undergo a…
Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
To deliver proof of concept that antifungal prophylaxis with posaconazole in addition to standard of care (SOC) can reduce the incidence of IAA in ICU patients with severe influenza, in comparison with SOC alone.To assess differences in cytokine…
Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…
The aim of this study is to analyse the analgetic effect of a local injection in the lateral femoral cutaneous nerve ( LFCN) with methylprednisolone/lidocaine (M/L) after localisation through elektro stimulation VS placebo. In this trial we hope to…
Primary* To explore the pharmacokinetics of insulin aspart after pulsed intra-vaginal delivery using the MedRing and after subcutaneous injection in women with DM1.Secondary* To assess the safety and short-term tolerability of insulin aspart after…
Primary objectives: To evaluate safety of ZED88082A in combination with CED88004S. To determine appropriate ZED88082A/CED88004S dosing and PET imaging time-points. To evaluate pharmacokinetics (PK) of ZED88082A/CED88004S in patients before and…
Primary objectives:The objective is to study the distribution of CD8+ T-cells before and after CAR T-cell therapy in the patient by ZED88082A/CED88004S-PET imaging. We will correlate the pretreatment CD8+ T-cell distribution and CD8+ CAR T-cell…
- In silico definition of the most optimal posaconazole dose for children and adolescents with CF aged 8 to 17 years.- Assess the prevalence of Aspergillus infection in children and adolescents with CF aged 8 -17 years.- An intensive sampling…