Febrile Neutropenia
Conditions
Keywords
Febrile neutropenia, Unexplained fever, Duration, Short-term antibiotic treatment
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
Interventions
OTHEREarly antibiotic discontinuation
Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
OTHERUsual practice
Continued antibiotic treatment as accepted by guidelines for febrile neutropenia
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-admission | 30 days | Rates of re-admission for any reason other than planned chemotherapy. |
| Antibiotic treatment | After day 7 from randomization until day 30 | Patients receiving antibiotic treatment after day 7 from randomization until day 30 |
| Antifungal treatment | 30 days | Institution of antifungal treatment |
| Duration of intravenous antibiotic treatment | 30 days | Duration of intravenous antibiotic treatment |
| Clinically and/or microbiologically documented infections | 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. |
| Development of resistance | 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 | 30 days | All-cause mortality |
| Infection-related mortality | 30 days after randomization | Cause of death adjudicated by the trial's safety committee |
| Duration of neutropenia | 30 days | Duration of neutropenia |
| Total in-hospital days | 30 days | Total in-hospital days from the day of randomization up to day 30 |
Countries
Israel
Outcome results
None listed