drugset / Trial / NCT02895529

A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy

NCT02895529 ↗

Phase 4 Terminated 61 enrolled Xian-Janssen Pharmaceutical Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate the hypothesis that the efficacy of intravenous (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofungin as empiric therapy for suspected fungal infection participants with fever and neutropenia.

Timeline

Start
2016-11-30
Primary completion
2018-05-02
Completion
2018-05-02

Outcome

Outcome not reported

Stopped: “Study is a commitment for license renew, we target on Apr19 submission, considering timeline, a cut off should be scheduled in Apr18.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Caspofungin Other / unclassified 50 mg Intravenous
Subject Itraconazole Small molecule 200 mg Intravenous