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

This study has been withdrawn prior to enrollment.
(slow recruitment, no funding)
Sponsor:
Information provided by (Responsible Party):
leibovici leonard, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01450241
First received: September 17, 2011
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Febrile Neutropenia
Other: Early antibiotic discontinuation
Other: Usual practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever [ Time Frame: After day 7 from randomization until day 30 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Clinically and/or microbiologically documented infections [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total in-hospital days from the day of randomization up to day 30

  • Re-admission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Rates of re-admission for any reason other than planned chemotherapy.

  • Antibiotic treatment [ Time Frame: After day 7 from randomization until day 30 ] [ Designated as safety issue: No ]
    Patients receiving antibiotic treatment after day 7 from randomization until day 30

  • Antifungal treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Institution of antifungal treatment

  • Duration of intravenous antibiotic treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Duration of intravenous antibiotic treatment

  • Duration of neutropenia [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Duration of neutropenia

  • Development of resistance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    All-cause mortality

  • Infection-related mortality [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    Cause of death adjudicated by the trial's safety committee


Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Early antibiotic discontinuation
Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
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.
Other: Usual practice
Continued antibiotic treatment as accepted by guidelines for 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450241

Locations
Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikvah, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mical Paul, MD Rabin Medical Center
Principal Investigator: Leonard Leibovici, Prof Rabin Medical Center
Principal Investigator: Dafna Yahav, MD Rabin Medical Center
  More Information

No publications provided

Responsible Party: leibovici leonard, Professor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01450241     History of Changes
Other Study ID Numbers: RabinMC6249
Study First Received: September 17, 2011
Last Updated: June 6, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Febrile neutropenia
Unexplained fever
Duration
Short-term antibiotic treatment

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 16, 2014