Stool Testing With Molecular Assay to Minimize Contact Precautions

NCT04189874 | Completed

• 1 other identifier: REB#R19-031
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of infectious diseases molecular-based stool testing compared to conventional stool testing on reducing the need for contact precautions among hospitalized patients. Half of patients' stools will be tested with the molecular assay , while the other half will be tested with conventional testing.

Conditions

Infectious Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Mean difference in hospital costs associated with contact isolation

  Direct hospital costs associated with contact isolation such as personal protective equipment, terminal cleaning, etc.. will be estimated for each arm and their mean difference estimated

  up to 1 year

Secondary Outcomes (6)

• 1. Mean difference in costs associated with differences in antimicrobial utilization

  up to 1 year

• 2. Difference in proportion of patients with any change in empiric antimicrobial treatment

  up to 1 year

• 3. Mean difference in costs associated with differences in diagnostic imaging utilization

  up to 1 year

• 4. Mean differences in costs associated with differences in endoscopy utilization

  up to 1 year

• 5. Mean difference in total costs associated with the composite outcome of (hospital days + antimicrobials + diagnostic imaging + endoscopy + contact isolation)

  up to 1 year

Study Arms (2)

Conventional stool testing

ACTIVE COMPARATOR

All patients randomly allocated to this arm will have their stools tested for the following: a) Bacterial culture for Salmonella, Shigella, E.coli O157 and Campylobacter - specimen in Enteric Pathogen Transport medium (EPT) planted to: i) MacConkey agar, Sorbitol-MacConkey agar, Hektoen agar and Selenite broth all incubated overnight at 350C ii) Campylobacter agar incubated for 48 hours at 420C in a microaerophilic atmosphere b) Bacterial culture for Yersinia (≤ 18 years old): EPT specimen sent to Dynacare Laboratories for processing, results back in 10-14 days c) Ova \& Parasites investigation: Sodium acetate-Acetic Acid-Formalin specimen sent to the Public Health Laboratories (PHL) for testing, results back in 7-10 days d) Viral culture: rarely requested, requires a specimen in a sterile container, sent to the PHL for testing, results back in 5-7 days e) Clostridioides difficile: specimen in sterile container, results in 1h (GeneXpert)

Diagnostic Test: Conventional Stool Testing

BioFire FilmArray Gastrointestinal Panel

EXPERIMENTAL

All patients randomly allocated to this arm will have their stools tested using a PCR-based molecular assay that can simultaneously test for 22 different infectious pathogens with a turnaround time of approximately 1 hour. As results become available, they will be available for review by the patient's healthcare providers in the electronic medical record.

Diagnostic Test: BioFire FilmArray Gastrointestinal Panel

Interventions

Conventional Stool Testing DIAGNOSTIC_TEST

Stools are tested using conventional culture techniques

Conventional stool testing

BioFire FilmArray Gastrointestinal Panel DIAGNOSTIC_TEST

Molecular-based stool assay

BioFire FilmArray Gastrointestinal Panel

Eligibility Criteria

• Age: 1 Month - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient in whom an appropriate stool sample has been collected and received by the microbiology laboratory that is:
• accompanied by a physician request for microbiologic testing for viruses, bacteria and/or parasites, and is
• appropriate for testing as determined by the microbiology laboratory standard (stool sample must have sufficient consistency to take shape of collection container), and
• patient is admitted to hospital
• Stool testing done between Monday 08:00 and Friday 14:00 a. The Infection Prevention and Control Practitioners (IPAC) are only available to review the stool test results between Monday 08:00 and Friday 17:00. Since IPAC is responsible for all decisions regarding contact isolation initiation and discontinuation, time delays from stool test reporting and decisions regarding contact isolation on the weekends or after 17:00 on weekdays would confound the primary outcome. As a result, FGP testing will only be available between Monday 08:00 and Friday 14:00 during the study period since each FGP test requires approximately 1 hour to complete, and the laboratory can only run 1 test at a time. Outside these hours, only conventional testing will be available.

You may not qualify if:

• Immunocompromised patients
• Investigation of possible diarrheal outbreak by either public health officials or infection prevention and control practitioners
• Nosocomial Clostridioides difficile infection defined as a positive polymerase chain reaction test in any patient who meets any of the following criteria:
• Has been hospitalized for ≥ 72 hours and then develops ≥ 3 loose bowel movements per day
• Develops ≥ 3 loose bowel movements per day regardless of length of hospital stay and has been hospitalized in the preceding 3 months for ≥ 48 hours

Sponsors & Collaborators

• Giulio DiDiodato: lead
• Biomerieux inc: collaborator

Study Sites (1)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

Location

Study Officials

• Giulio DiDiodato, PhD

  Royal Victoria Regional Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Research Scientist

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 6, 2019
• Study Start: December 18, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 12, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will become available after study recruitment closed and data has been cleaned. Data will be available indefinitely afterwards.
• Access Criteria: Email request

Locations

CA (1)