Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating 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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-10-31

Brief Summary

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This randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. Giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.

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Detailed Description

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OBJECTIVES:

I. The objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia.

OUTLINE: Patients are randomized 1 of 2 treatment arms.

All patients receive cefepime hydrochloride intravenously (IV) over 30 minutes as their first dose.

ARM I: Patients receive cefepime hydrochloride intravenously (IV) over 30 minutes.

ARM II: Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.

Conditions

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Adult Acute Lymphoblastic Leukemia Adult Acute Myeloid Leukemia Adult Burkitt Lymphoma Adult Diffuse Large Cell Lymphoma Adult Diffuse Mixed Cell Lymphoma Adult Diffuse Small Cleaved Cell Lymphoma Adult Hodgkin Lymphoma Adult Immunoblastic Large Cell Lymphoma Adult Lymphoblastic Lymphoma Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Breast Cancer Chronic Eosinophilic Leukemia Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Cutaneous T-cell Non-Hodgkin Lymphoma Disseminated Neuroblastoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3 Follicular Lymphoma Malignant Testicular Germ Cell Tumor Mantle Cell Lymphoma Marginal Zone Lymphoma Multiple Myeloma Mycosis Fungoides/Sezary Syndrome Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neutropenia Nodal Marginal Zone B-cell Lymphoma Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Plasma Cell Neoplasm Poor Prognosis Metastatic Gestational Trophoblastic Tumor Primary Myelofibrosis Prolymphocytic Leukemia Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma

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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Arm I (standard infusion)

Patients receive cefepime hydrochloride IV over 30 minutes.

Group Type EXPERIMENTAL

cefepime hydrochloride

Intervention Type DRUG

Given IV

Arm II (prolonged infusion)

Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours.

Group Type EXPERIMENTAL

cefepime hydrochloride

Intervention Type DRUG

Given IV

Interventions

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cefepime hydrochloride

Given IV

Intervention Type DRUG

Other Intervention Names

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cefepime Maxipime

Eligibility Criteria

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Inclusion Criteria

* Absolute neutrophil count \< 500 cells/mm\^3 or \< 1000 cells/mm\^3 with a predicted decrease to \< 500 cells/mm\^3
* Temperature \> 38.0 degrees Celsius
* Received chemotherapy or stem-cell transplant as treatment for malignancy or myelodysplastic syndrome (MDS)
* Cefepime prescribed at a dose of 2 grams IV every 8 hours

Exclusion Criteria

* Allergy to a cephalosporin antibiotic
* Estimated creatinine clearance \< 50 milliliters/minute
* Concurrent anti-gram negative antimicrobials
* Diagnostic criteria suggestive of sepsis
* Circumstances which may make 3 hour infusion impractical
* Solid tumor malignancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No