Back to resultsShort-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia
Primary Purpose
Febrile Neutropenia
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Early antibiotic discontinuation
Usual practice
Sponsored by
About this trial
This is an interventional treatment trial for Febrile Neutropenia focused on measuring Febrile neutropenia, Unexplained fever, Duration, Short-term antibiotic treatment
Eligibility 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
Sites / Locations
- Rabin Medical Center, Beilinson Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early antibiotic discontinuation
Usual practice
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
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
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
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
Total in-hospital days from the day of randomization up to day 30
Re-admission
Rates of re-admission for any reason other than planned chemotherapy.
Antibiotic treatment
Patients receiving antibiotic treatment after day 7 from randomization until day 30
Antifungal treatment
Institution of antifungal treatment
Duration of intravenous antibiotic treatment
Duration of intravenous antibiotic treatment
Duration of neutropenia
Duration of neutropenia
Development of resistance
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
All-cause mortality
Infection-related mortality
Cause of death adjudicated by the trial's safety committee
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01450241
Brief Title
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia
Official Title
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
slow recruitment, no funding
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia
Keywords
Febrile neutropenia, Unexplained fever, Duration, Short-term antibiotic treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early antibiotic discontinuation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual practice
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Early antibiotic discontinuation
Intervention Description
Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
Intervention Type
Other
Intervention Name(s)
Usual practice
Intervention Description
Continued antibiotic treatment as accepted by guidelines for febrile neutropenia
Primary Outcome Measure Information:
Title
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
Description
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)
Time Frame
After day 7 from randomization until day 30
Title
Total febrile or antibiotic days
Description
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
Time Frame
From the day of randomization until day 30
Secondary Outcome Measure Information:
Title
Clinically and/or microbiologically documented infections
Description
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.
Time Frame
30 days
Title
Total in-hospital days
Description
Total in-hospital days from the day of randomization up to day 30
Time Frame
30 days
Title
Re-admission
Description
Rates of re-admission for any reason other than planned chemotherapy.
Time Frame
30 days
Title
Antibiotic treatment
Description
Patients receiving antibiotic treatment after day 7 from randomization until day 30
Time Frame
After day 7 from randomization until day 30
Title
Antifungal treatment
Description
Institution of antifungal treatment
Time Frame
30 days
Title
Duration of intravenous antibiotic treatment
Description
Duration of intravenous antibiotic treatment
Time Frame
30 days
Title
Duration of neutropenia
Description
Duration of neutropenia
Time Frame
30 days
Title
Development of resistance
Description
Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.
Time Frame
30 days
Title
All-cause mortality
Description
All-cause mortality
Time Frame
30 days
Title
Infection-related mortality
Description
Cause of death adjudicated by the trial's safety committee
Time Frame
30 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mical Paul, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonard Leibovici, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dafna Yahav, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petah Tikvah
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia
We'll reach out to this number within 24 hrs