MERIDIAN BIOSCIENCE, INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2023-02-01: Study NCT05681156; Company role Lead sponsor; Phase Observational; Status Completed.
- 2022-02-03: Study NCT05322694; Company role Collaborator; Phase Observational; Status Completed.
- 2019-02-12: Study NCT03680898; Company role Lead sponsor; Phase Not applicable; Status Unknown.
- 2018-08-20: Study NCT03602976; Company role Collaborator; Phase Phase 2; Status Terminated.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2023-02-01 | NCT05681156 Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol | Lead sponsor | Observational | Completed | Streptococcus Pneumoniae Infection; Legionella Pneumophila Serogroup 1 Infection | 199 | 2023-09-08 |
| 2022-02-03 | NCT05322694 Clinical Decision Rules in the Emergency Department to Improve the Management of Acute Respiratory Infection and Acute Infectious Diarrhea | Collaborator Lead: Simon Berthelot | Observational | Completed | Acute Respiratory Infection; Acute Bacterial Diarrhea | 1,474 | 2023-03-31 |
| 2019-02-12 | NCT03680898 Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples. | Lead sponsor | Not applicable | Unknown | Carbapenem-Resistant Enterobacteriaceae | 1,200 | 2023-06-30 |
| 2018-08-20 | NCT03602976 Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis | Collaborator Lead: Ethan Weinberg | Phase 2 | Terminated Results posted | Hepatic Sarcoidosis, Elevated Alkaline Phosphatase | 7 | 2022-01-12 |
| 2018-05-04 | NCT03611101 Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials | Lead sponsor | Not applicable | Completed Results posted | NASH - Nonalcoholic Steatohepatitis | 124 | 2021-11-10 |
| 2018-02-14 | NCT03422341 Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs. | Lead sponsor | Not applicable | Completed | Pharyngitis, Infective | 497 | 2018-07-11 |
| 2017-08-02 | NCT03251261 Detection of Cytomegalovirus Virus in Neonates | Lead sponsor | Observational | Completed | CMV | 1,615 | 2018-03-05 |
| 2017-06-28 | NCT03462576 Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17 | Lead sponsor | Not applicable | Terminated Results posted | Decompensated Cirrhosis | 199 | 2019-07-15 |
| 2017-05-18 | NCT02905825 Urea Breath Test (UBT) With Breath Hp System /BreathID Hp Lab System Pediatrics | Lead sponsor | Phase 3 | Completed Results posted | Helicobacter Pylori Infection | 54 | 2017-11-05 |
| 2017-02-06 | NCT02968758 Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains | Lead sponsor | Not applicable | Completed Results posted | Clostridium Difficile Infection | 2,461 | 2017-08-10 |
| 2016-08-28 | NCT03439189 Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14 | Lead sponsor | Not applicable | Completed Results posted | NASH - Nonalcoholic Steatohepatitis; Cirrhosis; Portal Hypertension | 343 | 2019-05-13 |
| 2016-08-10 | NCT02718157 Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains | Lead sponsor | Not applicable | Completed Results posted | Streptococcus Agalactiae Infection | 771 | 2017-02-07 |
| 2016-06-10 | NCT02786836 13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF | Collaborator Lead: University of Texas Southwestern Medical Center | Phase 2, Phase 3 | Completed Results posted | Acute Liver Failure | 76 | 2019-09-18 |
| 2015-10 | NCT02528721 Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection | Lead sponsor | Phase 3 | Completed Results posted | Helicobacter Pylori Infection | 282 | 2016-07 |
| 2015-08 | NCT02511262 Detection of Mycoplasma Pneumoniae | Lead sponsor | Observational | Completed | Mycoplasma Pneumoniae | 471 | |
| 2015-06 | NCT02794805 Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis | Lead sponsor | Phase 2 | Completed | Hepatocellular Carcinoma (HCC) | 74 | 2017-04 |
| 2015-03 | NCT02314026 BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH | Lead sponsor | Phase 2 | Completed Results posted | Non-Alcoholic Steatohepatitis | 140 | 2017-06 |
| 2014-11 | NCT02143778 Assessing Portal Hypertension With Methacetin Breath Test | Lead sponsor | Not applicable | Completed Results posted | Patients With Compensated Liver Cirrhosis | 246 | 2019-01 |
| 2014-08 | NCT02187601 Equivalence of New Breath AnalyzerCompared to Currently BreathID System in Assessment of Liver Function | Lead sponsor | Not applicable | Completed | Chronic Liver Disease (CLD); Healthy Volunteers | 20 | 2017-03 |
| 2014-03-01 | NCT02055742 Detection of Chlamydia (CT) and Gonorrhea (NG) | Lead sponsor | Observational | Completed | Chlamydia; Gonorrhea | 700 | 2014-09-09 |
| 2014-03 | NCT02084160 Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation | Lead sponsor | Observational | Completed Results posted | Chronic Liver Disease | 579 | 2018-11 |
| 2014-01 | NCT02010112 Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori | Lead sponsor | Phase 3 | Completed | Helicobacter Pylori Infection | 193 | 2015-02 |
| 2013-10 | NCT01851252 MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy | Lead sponsor | Phase 1 | Completed | Chronic Liver Disease; Cirrhosis; Esophageal Varices; Portal Hypertension; Bleeding | 19 | 2017-08 |
| 2012-10 | NCT01650831 Show Equivalence of the Modified BreathID Compared to Currently Approved BreathID in H.Pylori Detection | Lead sponsor | Not applicable | Completed Results posted | Suspicion of Being Infected With H.Pylori | 113 | 2013-01 |
| 2011-11 | NCT01433016 Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI | Lead sponsor | Phase 2 | Terminated Results posted | Chronic Liver Disease; Hepatocellular Carcinoma (HCC) | 20 | 2013-05 |
| 2011-02 | NCT01244503 Prediction of Severity of Liver Disease by a 13C Octanoate Breath Test (OBT) | Collaborator Lead: Virginia Commonwealth University | Phase 2 | Terminated Results posted | Metabolic Syndrome; Nonalcoholic Fatty Liver Disease | 61 | 2012-06 |
| 2011-01 | NCT01281059 Prediction of Severity of Liver Disease Non Alcoholic Fatty Liver Disease in Patients With Suspected NAFLD by a 13C Octanoate Breath Test | Collaborator Lead: Hadassah Medical Organization | Not applicable | Unknown | NAFLD | ||
| 2010-09 | NCT01205074 ¹³C-Methacetin Breath Test (MBT) Methodology Study | Collaborator Lead: Hadassah Medical Organization | Phase 2, Phase 3 | Unknown | Healthy Subjects; Chronic Liver Disease; Cirrhosis | ||
| 2010-03 | NCT01157845 Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis | Collaborator Lead: Virginia Commonwealth University | Phase 3 | Completed Results posted | Cirrhosis | 165 | 2012-07 |
| 2009-01 | NCT01259544 BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency | Lead sponsor | Phase 2 | Completed | Chronic Pancreatitis; Healthy Volunteers | 33 | 2009-03 |
| 2008-11 | NCT00825630 13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors) | Lead sponsor | Phase 4 | Completed Results posted | Helicobacter Pylori Infection | 123 | 2009-11 |
| 2008-09 | NCT00375011 Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics | Lead sponsor | Observational | Terminated | Cirrhosis | 200 | 2011-10 |
| 2008-08 | NCT00736840 BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis | Lead sponsor | Phase 3 | Completed Results posted | Chronic Liver Disease | 414 | 2009-09 |
| 2006-07 | NCT00350714 BreathID Multi-center HCV Liver Breath Test Study | Lead sponsor | Phase 2 | Terminated | Hepatitis C | 75 | 2007-02 |