Posaconazole vs Itraconazole in Preventing IFD Post-HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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IFD Post-HSCT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

posaconazole oral suspension

Group Type EXPERIMENTAL

antifungal prophylaxis

Intervention Type DRUG

posaconazole oral suspension vs itraconazole oral solution

Arm 2

itraconazole oral solution

Group Type ACTIVE_COMPARATOR

antifungal prophylaxis

Intervention Type DRUG

posaconazole oral suspension vs itraconazole oral solution

Interventions

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antifungal prophylaxis

posaconazole oral suspension vs itraconazole oral solution

Intervention Type DRUG

Eligibility Criteria

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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%