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

18 Years
Not Enrolling
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

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Trial Information

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


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

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

Type of Study:


Study Design:

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

Outcome Measure:

Defervescence (without hypothermia)

Outcome Description:

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.

Outcome Time Frame:

72 hours

Safety Issue:


Principal Investigator

John Williamson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University


United States: Institutional Review Board

Study ID:

CCCWFU 02110



Start Date:

February 2011

Completion Date:

Related Keywords:

  • 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
  • Primary Myelofibrosis
  • Breast Neoplasms
  • Burkitt Lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Neutrophilic, Chronic
  • Leukemia, Prolymphocytic
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Mycoses
  • Mycosis Fungoides
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders
  • Neuroblastoma
  • Neutropenia
  • Sezary Syndrome
  • Testicular Neoplasms
  • Trophoblastic Neoplasms
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Neoplasms, Germ Cell and Embryonal
  • Hypereosinophilic Syndrome
  • Germinoma
  • Ovarian Neoplasms
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell
  • Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
  • Neoplasms, Glandular and Epithelial
  • Gestational Trophoblastic Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases



Wake Forest University Health Sciences Winston-Salem, North Carolina  27157