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

Wake Forest University (WFU)

Status and phase: Completed; Phase 1

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

Treatments: Drug: cefepime hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01484015

NCI-2011-02422 (Registry Identifier)

IRB00015247

CCCWFU 02110 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Arm I (standard infusion)

Experimental group

Description:

Patients receive cefepime hydrochloride IV over 30 minutes.

Treatment:

Drug: cefepime hydrochloride

Arm II (prolonged infusion)

Experimental group

Description:

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

Treatment:

Drug: cefepime hydrochloride