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Brain and Central Nervous System Tumors | Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia

Brain and Central Nervous System Tumors research study

What is the primary objective of this study?

RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia. PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.

Who is eligible to participate?

DISEASE CHARACTERISTICS: - Diagnosis of solid tumor or lymphoma AND meets the following criteria: - Low-risk patient, defined as Multinational Association for Supportive Care in Cancer prognostic index score ≥ 21 - Presents with neutropenic fever defined as follows: - Absolute neutrophil count ≤ 500/mm³ OR < 1,000/mm³ but anticipated to fall to ≤ 500/mm³ within 24 hours of study entry - Temperature ≥ 38.5°C on a single measurement or ≥ 38.0°C on > 1 occasion (one of which could be measured by the patient prior to admission) ≥ 1 hour apart - Undergoing concurrent cytotoxic chemotherapy for treatment of solid tumors or lymphoma - No leukemia PATIENT CHARACTERISTICS: - Compliant and appropriate for early discharge - Able to read a thermometer (patient or caregiver) - Able to tolerate oral medication - Must have a responsible adult caregiver if eligible for early discharge - No known allergy to oral antibiotics or penicillin - No requirement for IV fluid support - No central venous catheter-associated infection or evidence of infection not amenable to treatment by study antibiotics - No neutropenic fever at high risk of complications - No associated comorbidity that requires hospitalization and management - No known HIV positivity PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior participation in this study for neutropenic episode - No prior bone marrow transplantation or peripheral blood stem cell transplantation - No prior treatment for leukemia - More than 72 hours since prior antibiotics, including prophylactic antibiotics - Prophylactic septrin (for pneumocystis), acyclovir, or antifungals are allowed - No concurrent granulocyte colony-stimulating factor therapy

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Brain and Central Nervous System Tumors

Lymphoma

Neutropenia

Psychosocial Effects of Cancer and Its Treatment

Small Intestine Cancer

Unspecified Adult Solid Tumor, Protocol Specific

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:amoxicillin-clavulanate potassium

Drug:ciprofloxacin

Procedure:psychosocial assessment and care

Procedure:quality-of-life assessment

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: July 2007

Completed Date:

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Total number of days of hospitalization (including unplanned readmission) (randomized patients)

Secondary Outcome: Incidence of treatment failure as defined by the necessity for change in antibiotic therapy (randomized and registered patients)

Study sponsors, principal investigator, and references

Principal Investigator: Ernest Marshall, MD

Lead Sponsor: Clatterbridge Centre for Oncology

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00445497

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