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Not listed Not applicable Interventional Accepts healthy volunteers

Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.

ClinicalTrials.gov ID: NCT03680898

Public ClinicalTrials.gov record NCT03680898. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 10:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective Study for Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes of Gram-negative Bacteria (blaIMP, blaKPC, blaNDM, blaOXA-48-like and blaVIM) in Rectal Swab Samples From Patients Suspected of Being Colonized. The Targeted Organisms Are Enterobacteriaceae, Acinetobacter Baumannii, and Pseudomonas Aeruginosa.

Study identification

NCT ID
NCT03680898
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Meridian Bioscience, Inc.
Industry
Enrollment
1,200 participants

Conditions and interventions

Interventions

  • Rectal swab collection Device

Device

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 11, 2019
Primary completion
May 30, 2023
Completion
Jun 29, 2023
Last update posted
Apr 29, 2021

2019 – 2023

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Indiana University and Purdue University Institutions Indianapolis Indiana 46202
Henry Ford Health System Detroit Michigan 48202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03680898, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 29, 2021 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03680898 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →