Gastroenteritis Clinical Trial
Official title:
A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel (xTAG GPP) in Patients With Signs and Symptoms of Infectious Colitis and Gastroenteritis
The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the
presence or absence of gastrointestinal (GI) pathogens from human stool specimens.
The objective of this study is to establish diagnostic accuracy of the xTAG GPP.
The xTAG GPP assay is a qualitative nucleic acid multiplex test intended to simultaneously
detect and identify bacterial (and toxins), viral, and parasitic pathogens extracted from
human stool specimens collected from patients with signs and symptoms of infectious colitis
or gastroenteritis.
The objective of this study is to establish the diagnostic accuracy of xTAG GPP through a
multi-site, method comparison study on prospectively collected, left-over, and anonymized
stool specimens. The prospective sample set will also be supplemented with pre-selected
archived left-over specimens (for low prevalence targets only). Diagnostic accuracy will be
expressed in terms of clinical sensitivity and specificity for each target.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01168401 -
Bivalent Norovirus Vaccine Study
|
Phase 1 | |
| Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
| Completed |
NCT02473887 -
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
|
Phase 1 | |
| Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
| Not yet recruiting |
NCT01671137 -
Probiotic for the Prevention of Functional Disorders in Childhood
|
N/A | |
| Completed |
NCT01917461 -
Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections
|
N/A | |
| Withdrawn |
NCT00691275 -
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
|
N/A | |
| Recruiting |
NCT06025695 -
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
|
Phase 3 | |
| Completed |
NCT04463082 -
Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound
|
N/A | |
| Completed |
NCT02497417 -
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
|
N/A | |
| Active, not recruiting |
NCT03000296 -
Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease
|
N/A | |
| Completed |
NCT01225042 -
The Effect of Probiotics on E. Coli Gastroenteritis
|
N/A | |
| Completed |
NCT01236066 -
Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia
|
N/A | |
| Recruiting |
NCT00987519 -
Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age
|
N/A | |
| Terminated |
NCT01357174 -
ROTATEQ™ Post-Marketing Surveillance in the Philippines
|
N/A | |
| Completed |
NCT01033799 -
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
|
N/A | |
| Recruiting |
NCT01363726 -
Surveillance of Rotavirus Gastroenteritis in Children <5 Years
|
N/A | |
| Completed |
NCT00130832 -
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
|
Phase 3 | |
| Terminated |
NCT02568189 -
Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
|
N/A | |
| Terminated |
NCT02165813 -
Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children
|
Phase 2/Phase 3 |