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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Febrile Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Early antibiotic discontinuation

Intervention Type OTHER

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

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.

Group Type OTHER

Usual practice

Intervention Type OTHER

Continued antibiotic treatment as accepted by guidelines for febrile neutropenia

Interventions

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Early antibiotic discontinuation

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

Intervention Type OTHER

Usual practice

Continued antibiotic treatment as accepted by guidelines for febrile neutropenia

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No