Posaconazole vs Itraconazole in Preventing IFD Post-HSCT

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)

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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