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

Clalit Health Services

Status: Withdrawn

Conditions: Febrile Neutropenia

Treatments: Other: Usual practice; Other: Early antibiotic discontinuation

Study type: Interventional

Funder types: Other

Identifiers

NCT01450241

RabinMC6249

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Early antibiotic discontinuation

Experimental group

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.

Treatment:

Other: Early antibiotic discontinuation

Usual practice

Other group

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.

Treatment:

Other: Usual practice