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

Febrile Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01450241
• Other study ID #: RabinMC6249
• Status: Withdrawn
• Phase: N/A
• First received: September 17, 2011
• Last updated: June 6, 2013
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2013
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia

Intervention

Other:
• Early antibiotic discontinuation
Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
• Usual practice
Continued antibiotic treatment as accepted by guidelines for febrile neutropenia

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson Hospital	Petah Tikvah

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome of all-cause mortality, severe infection, severe diarrhea or fever	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)	After day 7 from randomization until day 30	No
Primary	Total febrile or antibiotic days	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	From the day of randomization until day 30	No
Secondary	Clinically and/or microbiologically documented infections	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.	30 days	No
Secondary	Total in-hospital days	Total in-hospital days from the day of randomization up to day 30	30 days	No
Secondary	Re-admission	Rates of re-admission for any reason other than planned chemotherapy.	30 days	No
Secondary	Antibiotic treatment	Patients receiving antibiotic treatment after day 7 from randomization until day 30	After day 7 from randomization until day 30	No
Secondary	Antifungal treatment	Institution of antifungal treatment	30 days	No
Secondary	Duration of intravenous antibiotic treatment	Duration of intravenous antibiotic treatment	30 days	No
Secondary	Duration of neutropenia	Duration of neutropenia	30 days	No
Secondary	Development of resistance	Development of resistance, defined as clinical isolates resistant to antibiotics previously used in the febrile episode. Surveillance sampling will not be conducted.	30 days	No
Secondary	All-cause mortality	All-cause mortality	30 days	Yes
Secondary	Infection-related mortality	Cause of death adjudicated by the trial's safety committee	30 days after randomization	Yes