Symptoms and General Pathology

Wounds and Injuries

All Conditions

Blood and Lymph Conditions

Behaviors and Mental Disorders

Rare Diseases

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Body Temperature Changes

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Stress Disorders, Traumatic

Heat Stress Disorders

Granulocytopenia

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Anti-Bacterial Agents

Amoxicillin

Tazobactam

Piperacillin

Clavulanic Acid

Piperacillin, Tazobactam Drug Combination

Amoxicillin-Potassium Clavulanate Combination

Levofloxacin

Ofloxacin

Penicillins

Antibiotics, Antitubercular

Clavulanic Acids

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.

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.

Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever

Early antibiotic discontinuation

Continued antibiotic treatment as accepted by guidelines for febrile neutropenia

Usual practice

Mical Paul, MD

Leonard Leibovici, Prof

Dafna Yahav, MD

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

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

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, 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

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.

Total in-hospital days from the day of randomization up to day 30

Rates of re-admission for any reason other than planned chemotherapy.

Patients receiving antibiotic treatment after day 7 from randomization until day 30

Duration of intravenous antibiotic treatment

Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.

Cause of death adjudicated by the trial's safety committee

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia	NCT01450241	Febrile Neutrop...	Early antibioti... Usual practice	18 Years -	Rabin Medical Center
Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia	NCT01450241	Febrile Neutrop...	Early antibioti... Usual practice	18 Years -	Rabin Medical Center

Spots Global Cancer Trial Database for unexplained fever