Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ernest Marshall
ORCID ID
Contact details
Clatterbridge Centre for Oncology NHS Trust
Clatterbridge Road
Bebington
Wirral
Merseyside
CH63 4JY
United Kingdom
+44 (0) 151 334 1155
emarshall@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00445497
Protocol/serial number
MX3006
Study information
Scientific title
Acronym
ORANGE, Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge
Study hypothesis
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
North West MREC approved on 30/05/2006 (ref. no.: 06/MRE08/31).
Study design
Two arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase III
Drug names
Ciprofloxacin and Coamoxyclav
Primary outcome measures
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 trial start date
01/07/2006
Overall trial end date
01/07/2009
Reason abandoned
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400 registered; 320 randomised
Participant 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
Recruitment start date
01/07/2006
Recruitment end date
01/07/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clatterbridge Centre for Oncology NHS Trust
Merseyside
CH63 4JY
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Research and Enterprise Services
Aitcheson Building
Birmingham
B15 2TT
United Kingdom
+44 (0) 121 414 3898
res-ent@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Clinical Trials Advisory & Awards Committee (CTAAC) Ref: C1810/A4818
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary