NCT03299894: qSOFAST

Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department

Completed NA Last updated 1 August 2018

What this trial tests

NA trial testing systematic calculation of qSOFA in Bacterial Infection in 780 participants. Completed in 10 June 2018.

Timeline

12 October 2017

Primary endpoint
10 June 2018

10 June 2018

Quick facts

Lead sponsor	Centre Hospitalier Régional d'Orléans
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	780
Start date	12 October 2017
Primary completion	10 June 2018
Estimated completion	10 June 2018
Sites	1 location across France

Drugs / interventions tested

• systematic calculation of qSOFA

Conditions studied

• Bacterial Infection — all drugs for Bacterial Infection →
• Intensive Care — all drugs for Intensive Care →

Sponsor

Centre Hospitalier Régional d'Orléans

Who can join

Adults 18 to 105, any sex, with Bacterial Infection or Intensive Care. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The delayed administration of an adequate antimicrobial therapy is a strong predictor of impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be initiated within one hour following the recognition of sepsis or septic shock.

The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which has been recently proposed by the Third International Sepsis Consensus Definitions Task Force (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min) and altered mentation (Glasgow coma scale \<15). The score ranges from 0 to 3 points. A qSOFA value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these outcomes being more common in infected patients who may be septic than in those with uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus improve the outcome of patients at risk of sepsis or septic shock.

Many patients admitted to the hospital for bacterial sepsis or septic shock are initially managed in the Emergency Department (ED). This study aims at investigating whether the routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial therapy in patients admitted to the ED with suspected or proven bacterial infection, especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3 definition).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of a qSOFA-based triage procedure on antibiotic timing in ED patients with sepsis: A prospective interventional study.
   Petit J, Passerieux J, Maître O, Guérin C, et al · · 2020 · cited 7× · PMID 31103379 · DOI 10.1016/j.ajem.2019.05.022