Early switch to oral antibiotic therapy in patients with low risk neutropenic sepsis: a randomised, controlled, non-inferiority trial with allocation concealment

Belfast Health and Social Care Trust (UK)0 sites129 target enrollmentJuly 1, 2015

Overview

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32460818/ protocol (added 29/05/2020)

Registry

who.int

Start Date

July 1, 2015

End Date

December 24, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Belfast Health and Social Care Trust (UK)

•Current inclusion criteria as of 05/04/2019:
•1\. Age over 16 years
•2\. Receiving SACT for a diagnosis of cancer
•3\. Started on empirical intravenous piperacillin/tazobactam or meropenem, for suspected NS, for less than 24 hours. Patients who have been started on additional antimicrobial drugs (eg. gentamicin or teicoplanin) are eligible provided the physician in charge of their care is willing to stop this additional antimicrobial at the time of enrolment.
•4\. Absolute neutrophil count \=1\.0x109/L with either a temperature of at least 38oC or other signs or symptoms consistent with clinically significant sepsis e.g. hypothermia. Self\-measurement at home or earlier hospital assessment of temperature are acceptable provided this is documented in medical notes and is within 24 hours prior to IV antibiotic administration.
•5\. Expected duration of neutropenia \<7 days
•6\. Low risk of complications using a validated risk score (MASCC score \=21\)
•7\. Able to maintain adequate oral intake and take oral medication
•8\. Adequate hepatic (AST \&/or ALT \<5xULN) and renal function (serum creatinine \<3 x ULN) within the 24 hours prior to randomisation
•9\. Physician in charge of care willing to follow either the intervention or standard care protocol per randomisation, at enrolment, including not treating with colony stimulating factor (CSF). Prophylactic CSF is not an exclusion criterion if prescribed routinely as an integral component of a specific SACT regimen.

•Current exclusion criteria as of 05/04/2019:
•1\. Underlying diagnosis of acute leukaemia or haematopoietic stem cell transplant
•2\. Hypotension (systolic pressure \<90mmHg or reduction of \>40mmHg from known baseline on \>1 measurement) within the 24 hours prior to randomisation
•3\. Prior allergy, serious adverse reaction, or contra\-indication to any study drug
•4\. Enrolled in this trial with prior episode of neutropenic sepsis
•5\. Previously documented as being colonised with an organism resistant to a study drug regimen e.g. MRSA
•6\. Localising signs of severe infection (pneumonia, soft tissue infection, central\-venous access device infection, presence of purulent collection)
•7\. Patients unable to provide informed consent
•8\. Pregnant women, women who have not yet reached the menopause (no menses for \= 12 months without an alternative medical cause) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry or are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial
•9\. Breastfeeding women