Fungal Infection Clinical Trial
Official title:
Prospective Trial to Evaluate Pharmacokinetic, Safety and Efficacy of Intermittent Application of Increased Doses of Caspofungin for Antifungal Prophylaxis in High Risk Patients
The study is a pilot phase II, prospective, non-comparative, single center trial aimed to evaluate pharmacokinetic and safety of an intermittent dosing schedule for antifungal prophylaxis in high risk patients.
Pharmacokinetic and safety of caspofungin, in an intermittent dosing schedule, for
prophylaxis of invasive fungal (IFI) infections will be evaluated in patients receiving
induction chemotherapy for treatment of acute myeloid leukemia, myelodysplastic syndrome
with blast crisis or acute lymphatic leukemia.
For prophylaxis caspofungin once daily will be given three times a week after a loading
phase of three days. For drug monitoring serum samples will be collected from the first day
of trial medication till one day after end of therapy (EOT). Invasive fungal infections will
be diagnosed analog the criteria defined by the European organization for Research and
Treatment of Cancer and the Mycosis Study Group (EORTC/MSG), revised in 2008.
Caspofungin prophylaxis will be stopped after the end of neutropenia, in case of documented
proven or probable invasive fungal disease and in case of a serious adverse event
attributable to the study drug, for which in view of the investigator further usage of the
study drug should be avoided.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03641131 -
Ampholipad Real-World Data in Taiwan
|
||
Not yet recruiting |
NCT03292224 -
Systemic Fungal Infections in ICU Patients
|
N/A | |
Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
Completed |
NCT00936117 -
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia
|
Phase 2 | |
Completed |
NCT00740389 -
TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects.
|
Phase 1 | |
Completed |
NCT03857399 -
Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin
|
Phase 2 | |
Not yet recruiting |
NCT04215458 -
Microbiota in Skin and Mucosa of Patients With Inflammatory Skin Diseases
|
N/A | |
Completed |
NCT03667690 -
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
|
Phase 3 | |
Completed |
NCT02957929 -
Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally
|
Phase 1 | |
Completed |
NCT01419678 -
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
|
N/A | |
Recruiting |
NCT00333645 -
Prophylaxis With Caspofungin in High-Risk Liver Transplantation
|
Phase 2 | |
Not yet recruiting |
NCT03650439 -
Fungal Infections in Patients With Hematological Malignancies
|
||
Completed |
NCT01303549 -
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
|
Phase 4 | |
Completed |
NCT00811642 -
Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
|
Phase 3 | |
Withdrawn |
NCT00430469 -
Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients
|
Phase 1/Phase 2 | |
Terminated |
NCT00386997 -
ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia
|
Phase 4 | |
Completed |
NCT00514358 -
Fluconazole Pharmacokinetics in Infants
|
Phase 1 | |
Completed |
NCT04166669 -
A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001
|
Phase 1 | |
Recruiting |
NCT05150327 -
Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
|
||
Completed |
NCT02387983 -
Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)
|
Phase 1 |