Chlamydia TrachomatisNCT02795975
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
An observational study of Chlamydia Trachomatis and Gonorrhea, run by Hologic, Inc. at 18 sites in United States.
Trial summary
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Trachomatis, Gonorrhea
- How many people
- 1,766 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Jun 2016to 1 Mar 2017
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Sexually active women ≥14 years of age with or without symptoms of STIs will be eligible for enrollment. Participating clinical collection sites may include US family planning, public health, and STI clinics.
Who may be able to join
- The subject is ≥14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months).
- For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB).
- The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and:
- reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or
- is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or
- is asymptomatic and undergoing screening evaluation for possible STIs; or
- is asymptomatic and undergoing a routine pelvic examination.
Who cannot join
- The subject took antibiotic medications within the last 21 days prior to collection.
- The subject already participated in the study.
- The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
LabCorp
Burlington, North Carolina, 27215
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, 77023
Eskenazi Hospital - Indiana University School of Medicine
Indianapolis, Indiana, 46202
Brownstone Clinical Trials
Irving, Texas, 75062
Beyer Research
Kalamazoo, Michigan, 49009
Clinical Trials Management, LLC
Mandeville, Louisiana, 70471
Geneuity
Maryville, Tennessee, 37804
Segal Institute for Clinical Research
Miami, Florida, 33161
Planned Parenthood of Southern New England, Inc
New Haven, Connecticut, 06511
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Multnomah County Health Department, STD Clinic
Portland, Oregon, 97204
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
University of Washington Center for AIDS & STD
Seattle, Washington, 98104
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, 23456
About this study
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.
- Conditions
- Chlamydia Trachomatis, Gonorrhea
- Medical subject headings
- Gonorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
Measured: Enrollment ongoing until estimated March 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start30 Jun 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: Sponsor business decision
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
- 1,766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795975
- Sponsor's protocol ID
- A10417-AC2PS-CSP-02
- Status last verified
- Mar 2017
- First submitted
- 2 Jun 2016
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. 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 in Female Urine Samples
- ClinicalTrials.gov ID
- NCT02795975
- Acronym / sponsor ID
- A10417-AC2PS-CSP-02
- Conditions
- Chlamydia Trachomatis, Gonorrhea
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor business decision
- Enrolment
- 1,766 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 10 Jun 2016 (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 study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sexually active women ≥14 years of age with or without symptoms of STIs will be eligible for enrollment. Participating clinical collection sites may include US family planning, public health, and STI clinics.
Key inclusion criteria (7 listed)
- The subject is ≥14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months).
- For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB).
- The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and:
- reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or
- is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or
Key exclusion criteria (3 listed)
- The subject took antibiotic medications within the last 21 days prior to collection.
- The subject already participated in the study.
- The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.
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
Sensitivity and specificity
Time frame: Enrollment ongoing until estimated March 2017
Results and safety
The study was stopped early (reason given: Sponsor business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 Hologic, Inc. at 18 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 stopped early (reason given: Sponsor business decision). 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?
Sensitivity and specificity (time frame: Enrollment ongoing until estimated March 2017). 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 24 Mar 2017.