Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia

Study Overview
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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.

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.

Official Title
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Prolonged Infusion Compared to Standard Infusion Cefepime as Empiric Treatment of Febrile Neutropenia: A Pilot Study

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

Intervention / Treatment
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* Drug: cefepime hydrochloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (standard infusion)<br>Patients receive cefepime hydrochloride IV over 30 minutes. | Drug: cefepime hydrochloride<br>* Given IV<br>* Other names: Maxipime;|
| Experimental: Arm II (prolonged infusion)<br>Patients receive cefepime hydrochloride IV over 3 hours. Treatment repeats every 8 hours. | Drug: cefepime hydrochloride<br>* Given IV<br>* Other names: Maxipime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defervescence (without hypothermia) | Comparison between groups will be done using the chi square test. T-tests will be used for continues variables. Survival data will be estimated using the Kaplan-Meier method, with the formal test of group comparisons done using Cox's Proportional Hazards Model. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success or failure |  | approximately 24 days | 
| Need for additional antimicrobials |  | approximately 24 days | 
| Mortality (in-house) |  | approximately 24 days | 
| Time to defervescence |  | approximately 24 days | 
| Hospital length of stay |  | approximately 24 days | 
| Successful treatment of baseline infection |  | approximately 24 days |