Chlamydia TrachomatisIO-CTNGNCT03071510
Evaluation of the Atlas Genetics io® CTNG System
An observational study of Chlamydia Trachomatis and Gonorrhea, run by Binx Health Limited at 10 sites in United States.
Trial summary
Atlas Genetics io® system results are compared with those obtained from comparator devices. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis, Gonorrhea
- What is being tested?
- Atlas Genetics io® system
- Type of treatment
- Medical device
- How many people
- 7,128 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 May 2017to 30 Aug 2019
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants over 14 years of age for whom testing for Chlamydia trachomatis and/or Neisseria gonorrhoeae is appropriate
Who may be able to join
- 1. Symptomatic and asymptomatic individuals ≥14 years of age
Who cannot join
- Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.
- Unable to self-obtain a vaginal swab or urine sample of at least 30 mL
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama
Birmingham, Alabama, 35294
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Wake Forest Center for Reproductive Medicine
Greensboro, North Carolina, 27455
Planned Parenthood Gulf Coast
Houston, Texas, 77023
Indiana University
Indianapolis, Indiana, 46202
University of Mississippi
Jackson, Mississippi, 39216
AIDS Healthcare Foundation
Los Angeles, California, 90046
Louisiana State University
New Orleans, Louisiana, 70112
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107
About this study
Official title: IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings
Atlas Genetics io® system results are compared with those obtained from comparator devices.
Read the detailed description
Results from the Atlas Genetics io® system are compared with a Composite Infection Status obtained from testing on three commonly used comparator devices.
This is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult participants over 14 years of age who are undergoing testing for the presence of CT/NG.
- Conditions
- Chlamydia Trachomatis, Gonorrhea
- Being tested
- Atlas Genetics io® system
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atlas Genetics io® systemDevice
Specimen Collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices
The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start18 May 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia TrachomatisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binx Health Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Van der Pol, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071510
- Sponsor's protocol ID
- MOB-VTP-001
- Acronym
- IO-CTNG
- Status last verified
- Apr 2020
- First submitted
- 27 Feb 2017
- Last updated
- 3 Apr 2020
- 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 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings
- ClinicalTrials.gov ID
- NCT03071510
- Acronym / sponsor ID
- IO-CTNG / MOB-VTP-001
- Conditions
- Chlamydia Trachomatis, Gonorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,128 participants (actual)
- Lead sponsor
- Binx Health LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 7 Mar 2017 (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.
Atlas Genetics io® system results are compared with those obtained from comparator devices.
Detailed description
Results from the Atlas Genetics io® system are compared with a Composite Infection Status obtained from testing on three commonly used comparator devices.
This is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult participants over 14 years of age who are undergoing testing for the presence of CT/NG.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants over 14 years of age for whom testing for Chlamydia trachomatis and/or Neisseria gonorrhoeae is appropriate
Key inclusion criteria (1 listed)
- 1. Symptomatic and asymptomatic individuals ≥14 years of age
Key exclusion criteria (2 listed)
- Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.
- Unable to self-obtain a vaginal swab or urine sample of at least 30 mL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atlas Genetics io® systemSpecimen Collection | Device | – |
Primary outcome
Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices
Time frame: Up to 7 days
The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- 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.
Barbara Van der Pol, PhD principal investigator
University of Alabama at Birmingham
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydia Trachomatis and Gonorrhea, run by Binx Health Limited at 10 sites in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices (time frame: Up to 7 days). 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 Apr 2020.