Clinical Trial: Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial

Brief Summary: The purpose of this study is to determine whether short-course antibiotic therapy is safe and effective for the treatment of cancer patients with febrile neutropenia.

Detailed Summary: Febrile neutropenia remains a major cause of morbidity in solid cancer patients. There is an unresolved question regarding the appropriate duration of antibiotic treatment for patients with febrile neutropenia of unknown origin. Current guidelines recommend at least seven days of antibiotic treatment. Several studies have demonstrated the safety of early antibiotic discontinuation in patients with febrile neutropenia. We plan an open label randomized controlled trial to compare early antibiotic discontinuation to the accepted prolonged antibiotic treatment protocol
Sponsor: Rabin Medical Center

Current Primary Outcome:

• Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever [ Time Frame: After day 7 from randomization until day 30 ]
  Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (>=3 daily for >=2 days) or fever (>38)
• Total febrile or antibiotic days [ Time Frame: From the day of randomization until day 30 ]
  Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement >38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis

Original Primary Outcome:

• Infection-related mortality [ Time Frame: 30 days ]
  Infection-related mortality, as adjudicated by the trial's safety committee
• Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever [ Time Frame: After day 7 from randomization until day 30 ]
  Composite outcome of all-cause mortality, severe infection (defined as clinically or microbiologically documented infection with systemic inflammatory response syndrome (SIRS)), severe diarrhea (>=3 daily for >=2 days) or fever (>38)
• Total febrile or antibiotic days [ Time Frame: From the day of randomization until day 30 ]
  Total febrile or antibiotic days from the day of randomization until day 30, defined as a day with one or more temperature measurement >38.0°C or a day on which antibiotic treatment was prescribed for any reason other than prophylaxis

Current Secondary Outcome:

• Clinically and/or microbiologically documented infections [ Time Frame: 30 days ]
  Clinically and/or microbiologically documented infections within 30 days of randomization. We will use the 2008 CDC/NHSN surveillance definitions of health-care associated infections for bacterial infections (including Clostridium difficile) and the 2008 revised definitions for invasive fungal infections.
• Total in-hospital days [ Time Frame: 30 days ]
  Total in-hospital days from the day of randomization up to day 30
• Re-admission [ Time Frame: 30 days ]
  Rates of re-admission for any reason other than planned chemotherapy.
• Antibiotic treatment [ Time Frame: After day 7 from randomization until day 30 ]
  Patients receiving antibiotic treatment after day 7 from randomization until day 30
• Antifungal treatment [ Time Frame: 30 days ]
  Institution of antifungal treatment
• Duration of intravenous antibiotic treatment [ Time Frame: 30 days ]
  Duration of intravenous antibiotic treatment
• Duration of neutropenia [ Time Frame: 30 days ]
  Duration of neutropenia
• Development of resistance [ Time Frame: 30 days ]
  Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.
• All-cause mortality [ Time Frame: 30 days ]
  All-cause mortality
• Infection-related mortality [ Time Frame: 30 days after randomization ]
  Cause of death adjudicated by the trial's safety committee

Original Secondary Outcome:

• Clinically and/or microbiologically documented infections [ Time Frame: 30 days ]
  Clinically and/or microbiologically documented infections within 30 days of randomization. We will use the 2008 CDC/NHSN surveillance definitions of health-care associated infections for bacterial infections (including Clostridium difficile) and the 2008 revised definitions for invasive fungal infections.
• Total in-hospital days [ Time Frame: 30 days ]
  Total in-hospital days from the day of randomization up to day 30
• Re-admission [ Time Frame: 30 days ]
  Rates of re-admission for any reason other than planned chemotherapy.
• Antibiotic treatment [ Time Frame: After day 7 from randomization until day 30 ]
  Patients receiving antibiotic treatment after day 7 from randomization until day 30
• Antifungal treatment [ Time Frame: 30 days ]
  Institution of antifungal treatment
• Duration of intravenous antibiotic treatment [ Time Frame: 30 days ]
  Duration of intravenous antibiotic treatment
• Duration of neutropenia [ Time Frame: 30 days ]
  Duration of neutropenia
• Development of resistance [ Time Frame: 30 days ]
  Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.
• All-cause mortality [ Time Frame: 30 days ]
  All-cause mortality

Information By: Rabin Medical Center

Dates:
Date Received: September 17, 2011
Date Started: January 2012
Date Completion: January 2015
Last Updated: June 6, 2013
Last Verified: June 2013