NCT02497417

Brief Summary

The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,021

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

July 9, 2015

Last Update Submit

August 22, 2017

Conditions

GastroenteritisInfectious Colitis

Keywords

ARIES Clostridium difficile

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

    Within the first year of sample collection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All comers

You may qualify if:

  • The specimen is from a patient suspected of having C. difficile associated disease (CDAD).
  • The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

You may not qualify if:

  • The specimen is preserved.
  • The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

TriCore Reference Laboratories

Albuquerque, New Mexico, 87102, United States

Location

The Ohio State University

Columbus, Ohio, 43205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ronald Dunn

    Luminex Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 14, 2015

Study Start

October 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

US(4)