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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03818477

Enrollment

8500

Registered

2019-01-28

Start date

2019-06-09

Completion date

2020-09-30

Last updated

2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polio

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

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 4 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Bangladesh

Outcome results