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NCT03680898
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
NA trial testing Rectal swab collection in Carbapenem-Resistant Enterobacteriaceae in 1,200 participants. Status unknown.
31 May 2023
Quick facts
| Lead sponsor | Meridian Bioscience, Inc. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,200 |
| Start date | 12 February 2019 |
| Primary completion | 31 May 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 3 locations across Canada, United States |
Drugs / interventions tested
- Rectal swab collection
Conditions studied
- Carbapenem-Resistant Enterobacteriaceae — all drugs for Carbapenem-Resistant Enterobacteriaceae →
Sponsor
Meridian Bioscience, Inc. — full company profile →
Who can join
2 and older, any sex, with Carbapenem-Resistant Enterobacteriaceae. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase Producing Organisms (CPOs) in rectal swab samples.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03680898
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rectal swab collection
Trials testing the same drug.
- NCT03569917 — Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Gener · NA · terminated
Other recruiting trials for Carbapenem-Resistant Enterobacteriaceae
Currently open trials in the same condition.
- NCT06001333 — Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract · NA · recruiting
Other Meridian Bioscience, Inc. trials
Trials by the same sponsor.
- NCT05681156 — Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol · completed
- NCT03611101 — Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials · completed
- NCT03422341 — Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs. · NA · completed
- NCT03251261 — Detection of Cytomegalovirus Virus in Neonates · completed
- NCT03462576 — Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03680898 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Meridian Bioscience, Inc.
- Last refreshed: 30 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03680898.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing