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

Condition(s) targeted: Febrile Neutropenia

Intervention: Early antibiotic discontinuation (Other); Usual practice (Other)

Phase: N/A

Status: Withdrawn

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Mical Paul, MD, Principal Investigator, Affiliation: Rabin Medical Center
Leonard Leibovici, Prof, Principal Investigator, Affiliation: Rabin Medical Center
Dafna Yahav, MD, Principal Investigator, Affiliation: Rabin Medical Center

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.

Official title: Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia: Randomized-controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever

Total febrile or antibiotic days

Secondary outcome:

Clinically and/or microbiologically documented infections

Total in-hospital days

Re-admission

Antibiotic treatment

Antifungal treatment

Duration of intravenous antibiotic treatment

Duration of neutropenia

Development of resistance

All-cause mortality

Infection-related mortality

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Rabin Medical Center, Beilinson Hospital, Petah Tikvah, Israel

Starting date: January 2012
Last updated: June 6, 2013