NCT03868241: CRITIC

Coated Devices to Decrease Infection in the Intensive Care Unit

Completed Phase 1, PHASE2 Last updated 9 March 2020

What this trial tests

Phase 1, PHASE2 trial testing Coated devices in Critically Ill in 103 participants. Completed in 28 February 2020.

Timeline

6 April 2019

Primary endpoint
13 February 2020

28 February 2020

Quick facts

Lead sponsor	Hospital do Coracao
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	103
Start date	6 April 2019
Primary completion	13 February 2020
Estimated completion	28 February 2020
Sites	6 locations across Brazil

Drugs / interventions tested

• Coated devices
• Control

Conditions studied

• Critically Ill — all drugs for Critically Ill →

Sponsor

Hospital do Coracao

Who can join

Adults 18 to 100, any sex, with Critically Ill. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.

Publications & conference data

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

1. Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit. CRITIC Pilot Randomized Controlled Trial.
   Zampieri FG, de Oliveira NE, Nassar AP, de Oliveira Manoel AL, et al · · 2020 · cited 5× · PMID 32526149 · DOI 10.1513/annalsats.202003-206oc