EASI-SWITCH v1.0
Research type
Research Study
Full title
Early switch to oral antibiotic therapy in patients with low risk neutropenic sepsis.
IRAS ID
184748
Contact name
Victoria Coyle
Contact email
Sponsor organisation
Belfast HSC Trust
Eudract number
2015-002830-35
ISRCTN Number
ISRCTN84288963
Duration of Study in the UK
3 years, 9 months, 0 days
Research summary
Neutropenic sepsis (infection in the setting of a low white blood cell count) is a potentially life-threatening complication of chemotherapy in cancer patients. There is universal agreement that prompt empirical antibiotic treatment is required, but less agreement about how best to manage patients thereafter.
This trial will evaluate whether changing from intravenous to oral antibiotics on the first day of treatment is clinically and cost-effective in comparison with longer duration intravenous antibiotics in patients at low risk of complications (identified using a previously validated risk score). In the intervention arm patients will switch from intravenous to oral antibiotics (ciprofloxacin and co-amoxiclav) to complete at least five days' antibiotic treatment, 12-24 hours after intravenous treatment commences. In the control arm, patients will receive standard care intravenous antibiotic (piperacillin/tazobactam or meropenem) for at least 48 hours with subsequent antibiotic continuation or switch to oral therapy at physician discretion.
The primary outcome is failure of treatment measured on day 14 of follow-up. This is defined as the presence of one of several clinical outcomes: persistence of fever after 72 hours of starting treatment; physician-directed escalation from protocol antibiotic treatment; re-admission to hospital; critical care admission and death. The study will also evaluate the effect of the different treatments on: antibiotic side-effects; quality of life; utilisation of health care resources, including length of hospital stay; cost-effectiveness; and death within 28 days.
628 patients in total are needed to definitively demonstrate that the proposed treatment intervention is not significantly less effective than standard care. The main expected advantages of the intervention (patients’ quality of life and resource utilisation) will also be measured. The trial will begin with a 6 month pilot phase, enrolling patients in 4 hospitals, to demonstrate feasibility followed by expansion to 12 hospitals across the UK over the next 30 months.
REC name
HSC REC A
REC reference
15/NI/0161
Date of REC Opinion
6 Oct 2015
REC opinion
Further Information Favourable Opinion