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

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ClinicalTrials.gov Identifier: NCT03818477
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Mami Taniuchi, PhD, 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.

Condition or disease
Polio

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

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Study Type : Observational
Estimated Enrollment : 8500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Evaluation of TaqMan Array Card for Environmental Surveillance of Polio Virus and Antimicrobial Resistance Genes
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Polymerase Chain Reaction (PCR) detection of poliovirus, enteric pathogens and antimicrobial resistance genes from environmental samples [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The investigators will conduct a Supplementary Immunization Activity (SIA) using bivalent oral polio vaccine (bOPV) and administer bOPV to at least 70% of all children under the age of 5 in the participating wards in the urban slums of Mirpur, Dhaka
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818477


Contacts
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Contact: Mami Taniuchi, PhD 434-924-5575 mt2f@virgnia.edu
Contact: Jennifer A White 434-982-3649 jaw9r@virginia.edu

Locations
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Bangladesh
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
Sponsors and Collaborators
University of Virginia
Bill and Melinda Gates Foundation
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Mami Taniuchi University of Virginia

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Responsible Party: Mami Taniuchi, PhD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03818477     History of Changes
Other Study ID Numbers: 21092
PR-18038 ( Other Identifier: International Centre for Diarrhoeal Disease Research )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases