Posaconazole vs Itraconazole in Preventing IFD Post-HSCT

F

Fujian Medical University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

IFD Post-HSCT

Treatments

Drug: antifungal prophylaxis

Study type

Interventional

Funder types

Other

Identifiers

NCT03631602
Posa-SCT-01

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Arm 1
Experimental group
Description:
posaconazole oral suspension
Treatment:
Drug: antifungal prophylaxis
Arm 2
Active Comparator group
Description:
itraconazole oral solution
Treatment:
Drug: antifungal prophylaxis

Trial contacts and locations

1

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Central trial contact

Ting Yang, Prof.M.D.Ph.D

Data sourced from clinicaltrials.gov

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