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]
Data Collection
Lymphadenopathy+58
+ Cytopenia
+ Agranulocytosis
Supportive Care Study
Summary
Study start date: July 1, 2007
Actual date on which the first participant was enrolled.OBJECTIVES: * 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, United KingdomOpen Gloucestershire Oncology Centre at Cheltenham General Hospital in Google MapsPrincess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, United KingdomLeicester Royal Infirmary
Leicester, United KingdomClatterbridge Centre for Oncology
Merseyside, United Kingdom