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

Not Applicable

Withdrawn

• Conditions: Febrile Neutropenia
• Interventions: Other: Early antibiotic discontinuation; Other: Usual practice

• Registration Number: NCT01450241
• Lead Sponsor: Rabin Medical Center

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

Study Timeline

• Study First Submitted: 2011-09-17
• Study First Submitted QC: 2011-10-09
• Study First Posted: 2011-10-12
• Study Start: 2012-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-07
• Primary Completion: 2014-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early antibiotic discontinuation	Early antibiotic discontinuation	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.
Usual practice	Usual practice	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.

Primary Outcome Measures

Name	Time	Method
Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever	After day 7 from randomization until day 30	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	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

Secondary Outcome Measures

Name	Time	Method
Clinically and/or microbiologically documented infections	30 days	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	30 days	Total in-hospital days from the day of randomization up to day 30
Re-admission	30 days	Rates of re-admission for any reason other than planned chemotherapy.
Antibiotic treatment	After day 7 from randomization until day 30	Patients receiving antibiotic treatment after day 7 from randomization until day 30
Antifungal treatment	30 days	Institution of antifungal treatment
Duration of intravenous antibiotic treatment	30 days	Duration of intravenous antibiotic treatment
Duration of neutropenia	30 days	Duration of neutropenia
Development of resistance	30 days	Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.
All-cause mortality	30 days	All-cause mortality
Infection-related mortality	30 days after randomization	Cause of death adjudicated by the trial's safety committee

Trial Locations

Locations (1)

Rabin Medical Center, Beilinson Hospital; 🇮🇱 Petah Tikvah, Israel