Posaconazole vs Itraconazole in Preventing IFD Post-HSCT

Phase 2

• Conditions: IFD Post-HSCT
• Interventions: Drug: antifungal prophylaxis

• Registration Number: NCT03631602
• Lead Sponsor: Fujian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Primary Completion: 2019-10-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	antifungal prophylaxis	posaconazole oral suspension
Arm 2	antifungal prophylaxis	itraconazole oral solution

Primary Outcome Measures

Name	Time	Method
Incidence of breakthrough IFD	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year
treatment-related mortality	1 year

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China