PolioNCT03818477
Environmental Surveillance (ES) for Polio and AMR Using the TaqMan Array Card
An observational study of Polio, run by University of Virginia at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages Up to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Polio
- How many people
- 8,500 participants
- Where
- 1 siteBangladesh
- Study dates
- 9 Jun 2019to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 years
- All sexes
- Healthy volunteers accepted
- 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
Who may be able to join
- birth-4 years of age
- reside in selected urban slums of Mirpur Dhaka, Bangladesh
- receiving bOPV immunization
Who cannot join
- parent unwilling to consent
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research
Dhaka
About this study
Official title: Evaluation of TaqMan Array Card for Environmental Surveillance of Polio Virus and Antimicrobial Resistance Genes
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.
Read the 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
- Conditions
- Polio
- Medical subject headings
- Poliomyelitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start9 Jun 2019
- Primary completion28 Feb 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolioStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 8,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Mami Taniuchi, PhD, University of Virginia
- Investigators
- Mami Taniuchi, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818477
- Sponsor's protocol ID
- 21092
- Other IDs
- PR-18038
- Status last verified
- Oct 2019
- First submitted
- 24 Jan 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TaqMan Array Card for Environmental Surveillance of Polio Virus and Antimicrobial Resistance Genes
- ClinicalTrials.gov ID
- NCT03818477
- Acronym / sponsor ID
- 21092
- Conditions
- Polio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,500 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 9 Jun 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- birth-4 years of age
- reside in selected urban slums of Mirpur Dhaka, Bangladesh
- receiving bOPV immunization
Key exclusion criteria (1 listed)
- parent unwilling to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mami Taniuchi principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polio, run by University of Virginia at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.