Chlamydia TrachomatisNCT01358799
Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
An observational study of Chlamydia Trachomatis, run by Gen-Probe, Incorporated at 7 sites in United States.
Trial summary
The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested 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
- What is being tested?
- APTIMA Assay for Chlamydia trachomatis
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2010to Jan 2012
- 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: 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 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 IRBapproved 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 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
Louisianna State University Health Center
New Orleans, Louisiana, 92122
About this study
The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
Read the detailed description
This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.
- Conditions
- Chlamydia Trachomatis
- Being tested
- APTIMA Assay for Chlamydia trachomatis
- Keywords
- Chlamydia trachomatis, APTIMA Assay for Chlamydia trachomatis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APTIMA Assay for Chlamydia trachomatisDevice
Also called Chlamydia trachomatis
APTIMA Assay for Chlamydia trachomatis
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
Measured: approximately one year
Secondary outcomes (1)
Positivity Rate
Positivity Rate
Measured: approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Assay not evaluated for purpose of clearance
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
- 0 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
- NCT01358799
- Sponsor's protocol ID
- ACTPS-US10-001
- Status last verified
- Mar 2013
- First submitted
- 20 May 2011
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System
- ClinicalTrials.gov ID
- NCT01358799
- Acronym / sponsor ID
- ACTPS-US10-001
- Conditions
- Chlamydia Trachomatis
- Keywords
- Chlamydia trachomatis, APTIMA Assay for Chlamydia trachomatis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Assay not evaluated for purpose of clearance
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 May 2011 (estimated)
- 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.
The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
Detailed description
This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.
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
- 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
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:
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 Assay for Chlamydia trachomatisAlso: Chlamydia trachomatisAPTIMA Assay for Chlamydia trachomatis | Device | – |
Primary outcome
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
Time frame: approximately one year
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference
1 secondary outcome
Positivity Rate
Time frame: approximately one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
Related trials for Chlamydia Trachomatis
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Not yet recruiting
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Recruiting
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
Chlamydia, Gonorrhea
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
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, 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: withdrawn, as of the sponsor's last update on 12 Mar 2013. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference (time frame: approximately one 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 12 Mar 2013.