Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial.
Administration, Intravenous
Administration, Oral
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
/ administration & dosage
Ciprofloxacin
Cost-Benefit Analysis
/ economics
Drug Administration Schedule
Equivalence Trials as Topic
Humans
Meropenem
Multicenter Studies as Topic
Neoplasms
/ complications
Neutropenia
/ drug therapy
Piperacillin
Pragmatic Clinical Trials as Topic
Quality of Life
Sepsis
/ drug therapy
Tazobactam
Treatment Outcome
Cancer
Low risk
Neutropenic sepsis
Non-inferiority
Oral antibiotics
Randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
27 May 2020
27 May 2020
Historique:
received:
29
10
2019
accepted:
10
03
2020
entrez:
29
5
2020
pubmed:
29
5
2020
medline:
20
2
2021
Statut:
epublish
Résumé
Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from empirical intravenous antibiotics to oral antibiotics within 48 h for patients assessed as low risk for septic complications because of uncertainty about whether this would achieve comparable outcomes to using intravenous antibiotics for longer. The UK National Institute for Health Research funded the EASI-SWITCH trial to tackle this uncertainty. The trial is a pragmatic, randomised, non-inferiority trial that aims to establish the clinical and cost-effectiveness of early switching from intravenous to oral antibiotics in cancer patients with low-risk neutropenic sepsis. Patients ≥ 16 years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of > 38 °C, neutrophil count ≤ 1.0 × 10 If the trial demonstrates non-inferiority of early switching to oral antibiotics, with potential benefits for patient quality of life and resource savings, this finding will have significant implications for the routine clinical management of those with low-risk neutropenic sepsis. ISRCTN: 84288963. Registered on the 1 July 2015. https://doi.org/10.1186/ISRCTN84288963. EudraCT: 2015-002830-35.
Sections du résumé
BACKGROUND
BACKGROUND
Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from empirical intravenous antibiotics to oral antibiotics within 48 h for patients assessed as low risk for septic complications because of uncertainty about whether this would achieve comparable outcomes to using intravenous antibiotics for longer. The UK National Institute for Health Research funded the EASI-SWITCH trial to tackle this uncertainty.
METHODS
METHODS
The trial is a pragmatic, randomised, non-inferiority trial that aims to establish the clinical and cost-effectiveness of early switching from intravenous to oral antibiotics in cancer patients with low-risk neutropenic sepsis. Patients ≥ 16 years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of > 38 °C, neutrophil count ≤ 1.0 × 10
DISCUSSION
CONCLUSIONS
If the trial demonstrates non-inferiority of early switching to oral antibiotics, with potential benefits for patient quality of life and resource savings, this finding will have significant implications for the routine clinical management of those with low-risk neutropenic sepsis.
TRIAL REGISTRATION
BACKGROUND
ISRCTN: 84288963. Registered on the 1 July 2015. https://doi.org/10.1186/ISRCTN84288963. EudraCT: 2015-002830-35.
Identifiants
pubmed: 32460818
doi: 10.1186/s13063-020-04241-1
pii: 10.1186/s13063-020-04241-1
pmc: PMC7251886
doi:
Substances chimiques
Anti-Bacterial Agents
0
Ciprofloxacin
5E8K9I0O4U
Amoxicillin-Potassium Clavulanate Combination
74469-00-4
Meropenem
FV9J3JU8B1
Tazobactam
SE10G96M8W
Piperacillin
X00B0D5O0E
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
431Subventions
Organisme : Department of Health
ID : 13/140/05
Pays : United Kingdom
Organisme : Medical Research Council
ID : G0901530
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 13/140/05
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