A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1021 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections

NCT01232595

Moderate Clostridium Difficile Infection

COMPLETED PHASE2

Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

NCT03110133

Clostridium Difficile Infection Recurrence

COMPLETED PHASE2

LMN-201 for Prevention of C. Difficile Infection Recurrence

NCT05330182

Clostridioides Difficile Infection

RECRUITING PHASE2/PHASE3

The Role of Mucosal Microbiome in Recurrence of Clostridioides Difficile Infection

NCT04675723

Clostridioides Difficile Infection

COMPLETED

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)

NCT05153499

Recurrent C. Difficile Infection

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile associated disease (CDAD).

The objective of this study is to establish diagnostic accuracy of ARIES C. difficile Assay through a multi-site, method comparison on prospectively collected, left-over, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroenteritis Infectious Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No