Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
NCT00034645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2017-03-10
Summary
This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).
Conditions
- Mycoses
Interventions
- DRUG
-
Posaconazole oral suspension
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-01-31
- Primary Completion
- 2003-02-28
- Completion
- 2003-02-28
More Related Trials
-
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
NCT00686543 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)
NCT00811928 ·Status: COMPLETED ·Phase: PHASE3
-
Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)
NCT00686621 ·Status: APPROVED_FOR_MARKETING
-
Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)
NCT00075803 ·Status: COMPLETED ·Phase: PHASE3
-
Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)
NCT00750737 ·Status: COMPLETED ·Phase: PHASE3
-
Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)
NCT00811642 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)
NCT01075984 ·Status: COMPLETED ·Phase: PHASE1
-
Posaconazole for Pulmonary Fungal Infection Prophylaxis in Hematopoietic Stem Cell Transplantation Patients
NCT04725942 ·Status: COMPLETED
-
Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)
NCT01777763 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
NCT00105144 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections
NCT02805946 ·Status: COMPLETED ·Phase: PHASE4
-
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
NCT01200355 ·Status: COMPLETED ·Phase: PHASE4
-
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
NCT00001937 ·Status: COMPLETED ·Phase: PHASE3
-
Posaconazole to Treat Invasive Fungal Infections
NCT00033982 ·Status: COMPLETED ·Phase: PHASE3
-
Ravuconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Stem Cell Transplantation
NCT00064311 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
NCT00606268 ·Status: COMPLETED ·Phase: PHASE1
-
Universal Prophylaxis Versus Pre-emptive Therapy With Posaconazole Post-Lung Transplant
NCT03561415 ·Status: UNKNOWN ·Phase: PHASE2
-
Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)
NCT00044486 ·Status: COMPLETED ·Phase: PHASE3
-
Posaconazole vs Itraconazole in Preventing IFD Post-HSCT
NCT03631602 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
NCT00520234 ·Status: COMPLETED ·Phase: PHASE4
-
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants
NCT03717623 ·Status: RECRUITING ·Phase: PHASE4
-
Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
NCT00003883 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
NCT00048750 ·Status: TERMINATED ·Phase: PHASE3
-
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
NCT03149055 ·Status: COMPLETED ·Phase: PHASE2
-
Voriconazole and Caspofungin Acetate in Treating Invasive Fungal Infections in Patients With Weakened Immune Systems
NCT00238355 ·Status: TERMINATED ·Phase: PHASE2