Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia
NCT ID: NCT00445497
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2007-07-31
Brief Summary
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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.
Detailed Description
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* Identify cancer patients who are low-risk inpatients and meet criteria for early discharge (i.e., symptomatic improvement and temperature ≤ 37.8°C) after receiving oral antibiotics for febrile neutropenia.
OUTLINE: This is a randomized, prospective, multicenter study. Patients are stratified by disease type (lymphoma vs solid tumor), duration of registration (\< 48 hours vs \> 48 hours), and participating center.
Patients receive oral amoxicillin-clavulanate potassium 3 times daily and oral ciprofloxacin twice daily on admission to the hospital. Treatment continues for 7 days in the absence of clinical deterioration or unacceptable toxicity. Patients are assessed as inpatients after ≥ 24 and up to 72 hours after the first antibiotic dose. Patients showing clear response (i.e., symptomatic improvement irrespective of neutrophil recovery, temperature ≤ 37.8 C for 24 hours) and who continue to meet study eligibility criteria are randomized to 1 of 2 arms.
* Arm I (early discharge): Patients are discharged home and instructed to remain in daily contact with hospital staff to report temperature and symptoms until completion of oral antibiotic regimen.
* Arm II (standard management): Patients continue their antibiotic course in hospital and are discharged according to local guidelines and the following additional criteria: subjective improvement, afebrile (≤ 37°C for 24 hours), and absolute neutrophil count ≥ 500/mm³ and rising.
Patients in both arms complete a daily diary documenting daily temperature readings, symptoms, and toxicities. Patients also complete a Health Questionnaire and a Cancer Worries Inventory Booklet at baseline, in the hospital immediately after randomization, and at completion of oral antibiotics or resolution of neutropenic febrile episode.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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amoxicillin-clavulanate potassium
ciprofloxacin
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Clatterbridge Centre for Oncology
OTHER
Principal Investigators
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Ernest Marshall, MD
Role: STUDY_CHAIR
Clatterbridge Centre for Oncology
Locations
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Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Airedale General Hospital
West Yorkshire, England, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
Ernest Marshall, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Other Identifiers
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CDR0000533828
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRUK-ORANGE
Identifier Type: -
Identifier Source: secondary_id
ISRCTN18467252
Identifier Type: -
Identifier Source: secondary_id
EU-20707
Identifier Type: -
Identifier Source: secondary_id
CRUK-MX3006
Identifier Type: -
Identifier Source: org_study_id