Status:
UNKNOWN
Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia
Lead Sponsor:
Clatterbridge Centre for Oncology
Conditions:
Brain and Central Nervous System Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00445497
Start Date
July 1 2007
Last Update
August 12 2013
Active Locations (10)
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1
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
2
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
Hull, England, United Kingdom, HU8 9HE
3
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
4
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY