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
ISRCTN | ISRCTN18467252 |
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DOI | https://doi.org/10.1186/ISRCTN18467252 |
ClinicalTrials.gov number | NCT00445497 |
Secondary identifying numbers | MX3006 |
- Submission date
- 03/07/2006
- Registration date
- 17/08/2006
- Last edited
- 05/11/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ernest Marshall
Scientific
Scientific
Clatterbridge Centre for Oncology NHS Trust
Clatterbridge Road
Bebington
Wirral
Merseyside
CH63 4JY
United Kingdom
Phone | +44 (0) 151 334 1155 |
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emarshall@nhs.net |
Study information
Study design | Two arm randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | ORANGE, Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge |
Study objectives | To determine, in the setting of the management of patients with solid tumours and lymphoma, whether in-patients treated with oral antibacterial therapy for neutropenic sepsis and at low risk for complications from infection can be identified for early discharge using the criteria of symptomatic improvement and temperature less than 37.8°C irrespective of neutrophil recovery. |
Ethics approval(s) | North West MREC approved on 30/05/2006 (ref. no.: 06/MRE08/31). |
Health condition(s) or problem(s) studied | Neutropenic sepsis |
Intervention | Treatment with oral Ciprofloxacin 750 mg twice daily and Co-amoxyclav 625 mg three times a day, and daily temperature readings. For the research arm patients will be discharged home early. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Ciprofloxacin and Coamoxyclav |
Primary outcome measure | 1. Total number of days of hospitalisation (including unplanned readmission) 2. Incidence of serious adverse events |
Secondary outcome measures | 1. Incidence of treatment failure as defined by the necessity for change in antibacterial therapy 2. Incidence of unplanned readmissions 3. Patient acceptability 4. Toxicity attributed to oral antibiotic therapy 5. Costs to health service |
Overall study start date | 01/07/2006 |
Completion date | 01/07/2009 |
Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 400 registered; 320 randomised |
Key inclusion criteria | 1. No previous participation in ORANGE for neutropenic episode 2. Undergoing cytotoxic chemotherapy to treat solid tumours or lymphoma 3. An Absolute Neutrophil Count (ANC) of more than or equal to 0.5 x 10^9 l. Patients are also eligible if their ANC is between 0.5 1 x 10^9 l but anticipated to fall to less than or equal to 0.5 x 10^9 l within 24 hours of entry into the study 4. A temperature of more than or equal to 38.5°C on a single measurement or more than 38.0°C on more than one occasion, at least one hour apart, one of which could be measured by the patient prior to admission 5. Patients with neutropenic fever (defined as above) at low risk of complications according to the Multinational Association of Supportive Care in Cancer (MASCC) prognostic index score more than or equal to 21 6. Age is 18 years or over 7. Compliant patient and appropriate for early discharge in the opinion of the investigator. All patients are required to have a responsible adult living with them who would be prepared to act as a carer if the patient were eligible for early discharge. Either patient or carer should be able to read a thermometer 8. Able to tolerate oral medication 9. Written informed consent obtained |
Key exclusion criteria | 1. Neutropenic fever judged by the clinician to be at high risk of complications 2. Allergies to oral antibiotics or penicillin used in ORANGE 3. Clinical condition necessitates intravenous fluid support 4. Central venous catheter associated infection or evidence of infection thought in the opinion of the investigator not to be adequately treated by the study antibiotics 5. Previous bone marrow transplant or peripheral blood stem cell transplant 6. Associated co-morbidity that requires hospitalisation and management 7. Received antibiotic therapy, including prophylactic antibiotics, within the last 72 hours (prophylactic septrin for pneumocystis, acyclovir or antifungals are acceptable) 8. Receiving Granulocyte Colony Stimulating Factor (G-CSF) 9. Known Human Immunodeficiency Virus (HIV) positive 10. Patients treated for leukaemia |
Date of first enrolment | 01/07/2006 |
Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clatterbridge Centre for Oncology NHS Trust
Merseyside
CH63 4JY
United Kingdom
CH63 4JY
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Research and Enterprise Services
Aitcheson Building
Birmingham
B15 2TT
England
United Kingdom
Phone | +44 (0) 121 414 3898 |
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res-ent@bham.ac.uk | |
Website | http://www.res.bham.ac.uk/ |
https://ror.org/03angcq70 |
Funders
Funder type
Charity
Clinical Trials Advisory & Awards Committee (CTAAC) Ref: C1810/A4818
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |