Pragmatic randomised controlled trial of molecular point-of-care testing for respiratory pathogens versus routine clinical care in critically ill adults with pneumonia: (SARIPOC) Trial protocol

Abstract

Trial site: University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD

Trial location: Intensive Care Units (ICUs) including General ICU (GICU) and Neurological ICU (NICU), and Respiratory High Dependency Unit (RHDU) within Southampton General Hospital, which is part of University Hospital Southampton UHS NHS Foundation Trust

Aim: To evaluate the clinical impact and safety of molecular point-of-care testing for respiratory pathogens in adults with pneumonia in critical care units

Design: Pragmatic, single centre, parallel group, randomised controlled trial.

Population: Adults aged 18 years old and over presenting to critical care (GICU, NICU and HDU) with pneumonia.

Sample Size: 200 participants (100 per group)

Randomisation: 1:1 allocation using randomisation software

Intervention: Lower respiratory tract sample tested for respiratory pathogens and genetic markers of resistance using the FilmArray® Pneumonia Panel with results interpreted and communicated to clinical team by infectious diseases specialist, in addition to standard care

Control: Standard clinical care alone

Key Assessment: Subsequent retrospective hospital case note evaluation of antimicrobial use and clinical outcomes

Timing: Three years for patient recruitment (with a further five years for laboratory analysis)

This trial is registered on the ISRCTN international clinical trials database: ISRCTN65693049

More information

Identifiers

ORCID for Tristan W. Clark: orcid.org/0000-0001-6026-5295

ORCID for Kordo Saeed: orcid.org/0000-0003-0123-0302

ORCID for Ahilanandan Dushianthan: orcid.org/0000-0002-0165-3359

ORCID for Mike Grocott: orcid.org/0000-0002-9484-7581

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