Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia
|ClinicalTrials.gov Identifier: NCT00445497|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : March 9, 2007
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Lymphoma Neutropenia Psychosocial Effects of Cancer and Its Treatment Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: amoxicillin-clavulanate potassium Drug: ciprofloxacin Procedure: psychosocial assessment and care Procedure: quality-of-life assessment||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective Randomised Phase III Trial of Early Hospital Discharge Versus Standard Inpatient Management of Cancer Patients With Low-Risk Febrile Neutropenia Receiving Oral Antibiotics. Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge [ORANGE]|
|Study Start Date :||July 2007|
|Estimated Primary Completion Date :||July 2010|
- Total number of days of hospitalization (including unplanned readmission) (randomized patients)
- Incidence of serious adverse events (randomized and registered patients)
- Incidence of treatment failure as defined by the necessity for change in antibiotic therapy (randomized and registered patients)
- Incidence of unplanned readmissions (randomized patients)
- Patient acceptability of randomized discharge policy as measured by Health Questionnaire, Cancer Worries Inventory Booklet, and Patient Daily Diary (randomized patients)
- Toxicity attributed to oral antibiotic therapy as measured by NCI CTCAE v3.0 (randomized and registered patients)
- Health service costs (randomized patients)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445497
|Gloucestershire Oncology Centre at Cheltenham General Hospital||Recruiting|
|Cheltenham, England, United Kingdom, GL53 7AN|
|Contact: Contact Person 44-0124-2222-2222|
|Princess Royal Hospital at Hull and East Yorkshire NHS Trust||Recruiting|
|Hull, England, United Kingdom, HU8 9HE|
|Contact: Contact Person 44-0148-2701151|
|Leicester Royal Infirmary||Recruiting|
|Leicester, England, United Kingdom, LE1 5WW|
|Contact: Contact Person 44-011-6254-1414|
|Clatterbridge Centre for Oncology||Recruiting|
|Merseyside, England, United Kingdom, CH63 4JY|
|Contact: Ernest Marshall, MD 44-151-334-1155|
|Northampton General Hospital||Recruiting|
|Northampton, England, United Kingdom, NN1 5BD|
|Contact: Contact Person 44-016-0463-4700|
|Peterborough Hospitals Trust||Recruiting|
|Peterborough, England, United Kingdom, PE3 6DA|
|Contact: Contact Person 44-0173-387-4000|
|Cancer Research Centre at Weston Park Hospital||Recruiting|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Contact: Contact Person 44-114-226-5000|
|Airedale General Hospital||Recruiting|
|West Yorkshire, England, United Kingdom, BD20 6TD|
|Contact: Contact Person 44-015-356-2511|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Contact: Contact Person 44-0114-226-5000|
|Bangor, Wales, United Kingdom, LL57 2PW|
|Contact: Contact Person 44-0124-838-4384|
|Study Chair:||Ernest Marshall, MD||Clatterbridge Centre for Oncology|