Chlamydia TrachomatisNCT01733069
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System
An observational study of Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection, run by Gen-Probe, Incorporated at 7 sites in United States.
Trial summary
The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System. 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, Neisseria Gonorrhoeae Infection
- What is being tested?
- APTIMA COMBO 2 Assay (AC2 Assay)
- Type of treatment
- Medical device
- How many people
- 1,912 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2010to Feb 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Male and Females at least 14 years of age at the time of informed consent and sexually active.
Who may be able to join
- •The subject is at least 14 years of age at the time of informed consent and is sexually active
- The subject reports symptoms consistent with a suspected STD (sexually transmitted disease) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.
- If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam
- The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an IRB (institutional review board) approved waiver for parental consent for minors)
Who cannot join
- •A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
- The subject took antibiotic medications within the last 21 days
- The subject is underage (as defined by the IRB (institutional review board) or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)
- The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Planned Parenthood Northeast Ohio
Akron, Ohio, 44302
University of North Carolina Chapel Hill STD Clinic
Chapel Hill, North Carolina, 27599
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, 45229
New England Center for Clinical Research
Fall River, Massachusetts, 02720
Planned Parenthood Houston and Southeast Texas
Houston, Texas, 77023
Wishard Health Services Department of Pathology Wishard Health Services
Indianapolis, Indiana, 46202
Louisiana State University Health Center
New Orleans, Louisiana, 70122
About this study
Official title: Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System
The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.
Read the detailed description
The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799).
The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).
- Being tested
- APTIMA COMBO 2 Assay (AC2 Assay)
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APTIMA COMBO 2 Assay (AC2 Assay)Device
APTIMA COMBO 2 Assay (AC2 Assay
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described Receives: Device: APTIMA COMBO 2 Assay (AC2 Assay) |
What is being measured
The primary outcome is the main question the study is designed to answer.
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 1,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gen-Probe, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Reid, PhD, Study director, Gen-Probe, Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733069
- Sponsor's protocol ID
- AC2PS-US11-001
- Other IDs
- ACTPS-US10-001
- Status last verified
- Nov 2013
- First submitted
- 20 Nov 2012
- Last updated
- 14 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System
- ClinicalTrials.gov ID
- NCT01733069
- Acronym / sponsor ID
- AC2PS-US11-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,912 participants (actual)
- Lead sponsor
- Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Posted 24 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.
Detailed description
The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799).
The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Device: APTIMA COMBO 2 Assay (AC2 Assay) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and Females at least 14 years of age at the time of informed consent and sexually active.
Key inclusion criteria (4 listed)
- •The subject is at least 14 years of age at the time of informed consent and is sexually active
- The subject reports symptoms consistent with a suspected STD (sexually transmitted disease) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.
- If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam
- The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an IRB (institutional review board) approved waiver for parental consent for minors)
Key exclusion criteria (4 listed)
- •A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
- The subject took antibiotic medications within the last 21 days
- The subject is underage (as defined by the IRB (institutional review board) or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)
- The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
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 |
|---|---|---|
| APTIMA COMBO 2 Assay (AC2 Assay)APTIMA COMBO 2 Assay (AC2 Assay | Device | No treatment |
Primary outcome
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type
Time frame: Baseline
Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer Reid, PhD study director
Gen-Probe, Incorporated
7 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 Neisseria Gonorrhoeae Infection, run by Gen-Probe, Incorporated at 7 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 4 inclusion and 4 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 24 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type (time frame: Baseline). 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 14 Jan 2014.