NCT03631602
Unknown
Phase 2
Posaconazole Oral Suspension and Itraconazole Oral Solution in Preventing Invasive Fungal Disease (IFD) in Patients With Hematopoietic Stem Cell Transplantation
Fujian Medical University1 site in 1 country120 target enrollmentStarted: October 1, 2017Last updated:
Overview
- Phase
- Phase 2
- Sponsor
- Fujian Medical University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence of breakthrough IFD
Overview
Brief Summary
Invasive Fungal Disease (IFD) after haematopoietic stem cell transplantation (HSCT) remain a clinical challenge.The studay aims to compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed written informed consent Aged ≥13 years Patients undergoing hematopoietic stem cell transplantation. Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70%
Exclusion Criteria
- •Pregnant or lactating females Any co-morbidity precluding the administration ofposaconazole or itraconazole
Arms & Interventions
Arm 1
Experimental
posaconazole oral suspension
Intervention: antifungal prophylaxis (Drug)
Arm 2
Active Comparator
itraconazole oral solution
Intervention: antifungal prophylaxis (Drug)
Outcomes
Primary Outcomes
Incidence of breakthrough IFD
Time Frame: 1 year
Secondary Outcomes
- Overall survival(1 year)
- treatment-related mortality(1 year)
Investigators
Ting YANG
Prof.M.D.Ph.D
Fujian Medical University
Study Sites (1)
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