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NCT Number: NCT01484015

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

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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Key information

Conditions

Adult Acute Lymphoblastic Leukemia Adnexal Diseases 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 Agranulocytosis Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blood Protein Disorders Bone Marrow Diseases Breast Cancer Breast Diseases Breast Neoplasms Burkitt Lymphoma Carcinoma Carcinoma, Ovarian Epithelial Cardiovascular Diseases Chronic Disease Chronic Eosinophilic Leukemia Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Cutaneous T-cell Non-Hodgkin Lymphoma Cytopenia DNA Virus Infections Disease Attributes Disseminated Neuroblastoma Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3 Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukocyte Disorders Leukopenia Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Malignant Testicular Germ Cell Tumor Mantle Cell Lymphoma Marginal Zone Lymphoma Multiple Myeloma Mycosis Fungoides Mycosis Fungoides/Sezary Syndrome Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasms Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Plasma Cell Neutropenia Nodal Marginal Zone B-cell Lymphoma Ovarian Diseases Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Ovarian Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Plasma Cell Neoplasm Poor Prognosis Metastatic Gestational Trophoblastic Tumor Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Prolymphocytic Leukemia Sezary Syndrome Skin Diseases Skin and Connective Tissue Diseases Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma Testicular Diseases Testicular Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cefepime hydrochloride

Drug

Given IV

Other names: cefepime, Maxipime

Primary outcomes

  1. Defervescence (without hypothermia)

    Time frame: 72 hours

    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.

Secondary outcomes

  1. Clinical success or failure

    Time frame: approximately 24 days

  2. Need for additional antimicrobials

    Time frame: approximately 24 days

  3. Mortality (in-house)

    Time frame: approximately 24 days

  4. Time to defervescence

    Time frame: approximately 24 days

  5. Hospital length of stay

    Time frame: approximately 24 days

  6. Successful treatment of baseline infection

    Time frame: approximately 24 days

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2011
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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