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

niversity of Birmingham (UK)0 个研究点目标入组 400 人开始时间: 2006年8月17日最近更新: 2015年1月13日

试验速览

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•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

•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

发起方

niversity of Birmingham (UK)