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

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ClinicalTrials.gov Identifier: NCT01450241
Recruitment Status : Withdrawn (slow recruitment, no funding)
First Posted : October 12, 2011
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
leibovici leonard, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE September 17, 2011
First Posted Date  ICMJE October 12, 2011
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • 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 Measures  ICMJE
 (submitted: October 9, 2011)
  • 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
Change History Complete list of historical versions of study NCT01450241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
  • 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 Measures  ICMJE
 (submitted: October 9, 2011)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia
Official Title  ICMJE 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 Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Febrile Neutropenia
Intervention  ICMJE
  • Other: Early antibiotic discontinuation
    Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
  • Other: Usual practice
    Continued antibiotic treatment as accepted by guidelines for febrile neutropenia
Study Arms  ICMJE
  • Experimental: Early antibiotic discontinuation
    Antibiotic treatment stopped after 72h, regardless of fever.The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively.
    Intervention: Other: Early antibiotic discontinuation
  • Usual practice
    Antibiotic treatment continued according to accepted guidelines and current clinical practice. The antibiotics used will be piperacillin tazobactam for high-risk patients and amoxycillin-clavulanate + ciprlofloxacin for low-risk patients (defined by MASCC scoring system). Alternatives in case of penicillin allergy will be ceftazidine and levofloxacin, respectively.
    Intervention: Other: Usual practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 6, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2011)
546
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults >18 years providing signed informed consent
  • Patients with solid tumors, lymphoma, multiple myeloma or chronic lymphocytic leukemia, regardless of disease status or previous chemotherapy
  • Documented febrile neutropenia
  • No clinically or microbiologically documented infection after 72 hours

Exclusion Criteria:

  • Previous enrollment in this study
  • Concurrent participation in another interventional trial
  • Severe sepsis or septic shock
  • Acute leukemia, autologous or allogeneic hematopoietic stem-cell transplantation
  • Diarrhea suspected by treating physician to be Irinotecan induced
  • Any antibiotic treatment for >48h in the last week before enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01450241
Other Study ID Numbers  ICMJE RabinMC6249
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party leibovici leonard, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mical Paul, MD Rabin Medical Center
Principal Investigator: Leonard Leibovici, Prof Rabin Medical Center
Principal Investigator: Dafna Yahav, MD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP