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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Randomized Trial Comparing The Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Subjects With Hematologic

Brief 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.

Detailed Summary:
Sponsor: Xian-Janssen Pharmaceutical Ltd.

Current Primary Outcome: Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints [ Time Frame: Up to 36 days ]

Response rate in each of the 2 treatment groups will be measured by the percentage of participants that achieve all of the following 5 composite endpoints: 1) survival for 7 days after completion of treatment, 2) absence of breakthrough invasive fungal infection during the study drug administration and within the first 7 days after completion of treatment, 3) successful treatment of baseline fungal infection, 4) defervescence and 5) no premature withdrawal from the study due to drug-related toxicity or lack of efficacy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of Participants With Survival for 7 Days After Completion of Treatment [ Time Frame: Up to 36 days ]
  • Percentage of Participants With Absence of Breakthrough Invasive Fungal Infection [ Time Frame: Up to 36 days ]
    Absence of breakthrough invasive fungal infection is defined as the fungal infection with an onset on or after Day 3 of the study) during the study drug administration and within the first 7 days after completion of treatment.
  • Percentage of Participants With Successful Treatment of Baseline Fungal Infection [ Time Frame: Up to 36 days ]
    Successful treatment of baseline fungal infection is defined as the clinically and microbiologically documented fungal infection with an onset within 2 days before or after the study treatment.
  • Percentage of Participants With Defervescence During the Period of Neutropenia [ Time Frame: Up to 36 days ]
    Defervescence is defined as body temperature less than (<) 38 degree celsius for over 48 hours) during the period of neutropenia.
  • Percentage of Participants With No Premature Withdrawal From the Study due to Drug-related Toxicity or Lack of Efficacy [ Time Frame: Up to 36 days ]
  • Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints With Oral Administration of Itraconazole [ Time Frame: Up to 36 days ]
    Response rate will be measured by the percentage of participants (who received oral administration of itraconazole) that achieve all of the following 5 composite endpoints: 1) survival for 7 days after completion of treatment, 2) absence of breakthrough invasive fungal infection during the study drug administration and within the first 7 days after completion of treatment, 3) successful treatment of baseline fungal infection, 4) defervescence and 5) no premature withdrawal from the study due to drug-related toxicity or lack of efficacy.


Original Secondary Outcome: Same as current

Information By: Xian-Janssen Pharmaceutical Ltd.

Dates:
Date Received: September 6, 2016
Date Started: November 30, 2016
Date Completion: August 15, 2018
Last Updated: May 16, 2017
Last Verified: May 2017