Clinical trial NCT01450241: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Febrile Neutropenia
Keywords: Febrile neutropenia
Unexplained fever
Duration
Short-term antibiotic treatment
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

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

Primary outcomes:
measure: Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever
timeFrame: After day 7 from randomization until day 30
measure: Total febrile or antibiotic days
timeFrame: From the day of randomization until day 30
Secondary outcomes:
measure: Clinically and/or microbiologically documented infections
timeFrame: 30 days
measure: Total in-hospital days
timeFrame: 30 days
measure: Re-admission
timeFrame: 30 days
measure: Antibiotic treatment
timeFrame: After day 7 from randomization until day 30
measure: Antifungal treatment
timeFrame: 30 days
measure: Duration of intravenous antibiotic treatment
timeFrame: 30 days
measure: Duration of neutropenia
timeFrame: 30 days
measure: Development of resistance
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
measure: Infection-related mortality
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: Petah Tikvah
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center
name: Mical Paul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center
name: Leonard Leibovici, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center
name: Dafna Yahav, MD
role: PRINCIPAL_INVESTIGATOR
References: