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

• Conditions: Polio

• Registration Number: NCT03818477
• Lead Sponsor: University of Virginia

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-06-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-03
• Primary Completion: 2020-02-28
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8500

Inclusion Criteria

Not provided

Exclusion Criteria

• parent unwilling to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Polymerase Chain Reaction (PCR) detection of poliovirus, enteric pathogens and antimicrobial resistance genes from environmental samples	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research; 🇧🇩 Dhaka, Bangladesh