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

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

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.

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

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