NCT04014608

Protocol for Admission Toxigenic C. Difficile Surveillance

Completed Last updated 10 September 2019

What this trial tests

trial testing Standard Practice to Prevent Hospital Onset CDI in Clostridium Difficile Infection in 148,549 participants. Completed in 31 December 2018.

Timeline

1 July 2016

Primary endpoint
31 December 2016

31 December 2018

Quick facts

Lead sponsor	Endeavor Health
Status	Completed
Study type	OBSERVATIONAL
Enrollment	148,549
Start date	1 July 2016
Primary completion	31 December 2016
Estimated completion	31 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Standard Practice to Prevent Hospital Onset CDI

Conditions studied

• Clostridium Difficile Infection — all drugs for Clostridium Difficile Infection →

Sponsor

Endeavor Health — full company profile →

Who can join

Under 1, any sex, with Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Clostridioides (formerly Clostridium) difficile Infection (CDI) is a persistent healthcare issue. In the US, CDI is the most common infectious cause of hospital-onset (HO) diarrhea.

Objective: Assess the impact of admission testing for toxigenic C. difficile colonization on the incidence of clinical disease.

Design: Pragmatic stepped-wedge Infection Control initiative. Setting: NorthShore University HealthSystem (NorthShore) is a four-hospital system near Chicago, Illinois.

Patients: All patients admitted to the four hospitals during the initiative. Interventions: From September 2017 through August 2018 the investigators conducted a quality improvement program where admitted patients had a peri-rectal swab tested for toxigenic C. difficile. All colonized patients were placed in contact precautions.

Measurements: The investigators tested admissions who: i) had been hospitalized within two months, ii) had a past C. difficile positive test, and/or iii) were in a long-term care facility within six months. The investigators measured compliance with all other measures to reduce the incidence of HO-CDI.

Limitations: This was not a randomized controlled trial, and multiple prevention interventions were in place at the time of the admission surveillance initiative.

Publications & conference data

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

1. Reduced Clostridioides difficile infection in a pragmatic stepped-wedge initiative using admission surveillance to detect colonization.
   Peterson LR, O'Grady S, Keegan M, Fisher A, et al · · 2020 · cited 5× · PMID 32191763 · DOI 10.1371/journal.pone.0230475