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NCT03818477 Clinical Trial

Environmental Surveillance (ES) for Polio and AMR Using the TaqMan Array Card

Polio Clinical Trial

Official title:
Evaluation of TaqMan Array Card for Environmental Surveillance of Polio Virus and Antimicrobial Resistance Genes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03818477
Other study ID # 21092
Secondary ID PR-18038
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 9, 2019
Est. completion date September 2020

Study information
Verified date October 2019
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will be used to develop a tool to streamline poliovirus environmental surveillance for the polio endgame and to provide a tool for detecting polio in places where there is no capacity to carry out the gold standard culture-based detection.

Description:

This environmental surveillance tool will also include antimicrobial resistance (AMR) genes to describe resistome profile in environmental samples and to better inform us of the potential risks of exposure to these environments

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 8500
Est. completion date September 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Years
Eligibility Inclusion Criteria

- birth-4 years of age

- reside in selected urban slums of Mirpur Dhaka, Bangladesh

- receiving bOPV immunization

Exclusion Criteria:

- parent unwilling to consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Bangladesh International Centre for Diarrhoeal Disease Research Dhaka

Sponsors (3)
Lead Sponsor Collaborator
University of Virginia Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome
Type Measure Description Time frame Safety issue
Primary Polymerase Chain Reaction (PCR) detection of poliovirus, enteric pathogens and antimicrobial resistance genes from environmental samples Evaluate performance of the TaqMan Array Card (TAC) on environmental samples (sewage samples) collected in urban slum area of Mirpur. The primary purpose will be to use TAC to detect and monitor Sabin 1 and 3 polio viruses post SIA. through study completion, an average of 1 year
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