Environmental Surveillance (ES) for Polio and AMR Using t... | NCT03818477

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

NCT03818477

Sponsor

University of Virginia

Status

Unknown status

Last Update Posted

Oct 3, 2019Actual

Enrollment

8,500Estimated

Phase

Not provided

Conditions

Polio

Interventions

Not provided

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PR-18038	Other Identifier	International Centre for Diarrhoeal Disease Research

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 9, 2019Actual

Primary Completion Date

Feb 28, 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jan 24, 2019

First Submission Date that Met QC Criteria

Jan 25, 2019

First Posted Date

Jan 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2019

Last Update Posted Date

Oct 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mami Taniuchi, PhD, Assistant Professor, University of VirginiaPrincipal Investigator

Lead Sponsor

University of VirginiaOTHER

Collaborators

Name	Class
Bill and Melinda Gates Foundation	OTHER
International Centre for Diarrhoeal Disease Research, Bangladesh	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

4 Years

Standard Ages

Child

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mami Taniuchi	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Centre for Diarrhoeal Disease Research		Dhaka			Bangladesh

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011051	Poliomyelitis

Ancestor Terms

ID	Term
D009187	Myelitis
D002494	Central Nervous System Infections
D007239	Infections
D004769	Enterovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided