Fungal Infections Clinical Trial
Official title:
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin as an Antifungal Prophylaxis in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplant
The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT
This is a prospective, multi-center, open-label, repeat-dose pharmacokinetic study that
contains two treatment (micafungin 1.0mg/kg and 1.5mg/kg) dose groups. Subjects will be
enrolled according to age and stratified by weight to receive either 1.0mg/kg (weight >
25kg) or 1.5mg/kg ( weight < 25kg) micafungin.
Children (4 months to < 2years, 2 to 5 years and 6 to 11 years) and adolescents (12 to 16
years) undergoing HSCT who require antifungal prophylaxis will be enrolled
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01782131 -
A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)
|
Phase 3 | |
| Completed |
NCT02631954 -
Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00177684 -
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
|
Phase 3 | |
| Recruiting |
NCT01684189 -
Registry of Febrile Neutropenia and Invasive Fungal Infections
|
N/A | |
| Completed |
NCT00794703 -
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
|
Phase 3 | |
| Completed |
NCT00353158 -
A Pilot of Pediatric/Adult Study of Gene Expression Profiling and Clinical Characterization of Phototoxicity
|
Phase 1 | |
| Completed |
NCT01777763 -
Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)
|
Phase 1 | |
| Recruiting |
NCT01222741 -
Studies of Disorders With Increased Susceptibility to Fungal Infections
|
||
| Completed |
NCT02358499 -
Genetic Variation and Variability in Posaconazole Pharmacokinetics in Children
|
Phase 1 | |
| Completed |
NCT00177710 -
Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study
|
Phase 3 | |
| Enrolling by invitation |
NCT03793231 -
fungalAi for Fungal Surveillance & Antifungal Stewardship
|
||
| Completed |
NCT02025699 -
Prospective Study to Characterize Host-pathogen Related Factors in Hospitalized and ED Patients With LRTI and/or Sepsis
|
N/A | |
| Completed |
NCT01436578 -
Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)
|
N/A | |
| Completed |
NCT00876096 -
Interest of Real-time Polymerase Chain Reaction (PCR) in the Diagnosis of Fungal Infections
|
N/A | |
| Completed |
NCT02306330 -
MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial
|
N/A | |
| Not yet recruiting |
NCT01105013 -
Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
|
Phase 3 | |
| Terminated |
NCT01716234 -
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
|
Phase 1 | |
| Recruiting |
NCT05336851 -
Emergency PWAS in Respiratory Infectious Disease
|