Chlamydia InfectionsNCT01728103
Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
An observational study of Chlamydia Infections and Gonorrhea, run by Gen-Probe, Incorporated at 14 sites in United States.
Trial summary
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Infections, Gonorrhea, Trichomonas Infections
- What is being tested?
- APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
- Type of treatment
- Medical device
- How many people
- 1,336 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2013to Jul 2014
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.
Who may be able to join
- The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal intercourse within the past 12 months)
- 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 institutional review board [IRB]-approved waiver for parental consent for minors)
- In addition, the subject must meet at least one of the following criteria:
- The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
- Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
- Subject is asymptomatic and undergoing screening evaluation for possible STIs
- Subject is asymptomatic and undergoing a routine examination with a pelvic examination
Who cannot join
- The subject took antibiotic medications within the last 21 days
- Subject already participated in this study
- Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
- Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
John Hopkins University
Baltimore, Maryland, 21205
Infectious Diseases STD Program University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599-7030
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, 45229-3039
New England Center for Clinical Research
Fall River, Massachusetts, 02720
Planned Parenthood Gulf Coast
Houston, Texas, 77023
The Jackson Clinic
Jackson, Tennessee, 38305
Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
New Orleans, Louisiana, 70112
Tidewater Clinical Research
Norfolk, Virginia, 23502
Healthcare Clinical Data
North Miami, Florida, 33161
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107
Medical Center for Clinical Research
San Diego, California, 92108
Mount Vernon Clinical Research
Sandy Springs, Georgia, 30328
About this study
Official title: Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays
The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.
- Conditions
- Chlamydia Infections, Gonorrhea, Trichomonas Infections
- Being tested
- APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays
- Medical subject headings
- Chlamydia Infections, Gonorrhea, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® AssaysDevice
In Vitro Diagnostic Assays
| Study group | Role | What they receive |
|---|---|---|
| No Treatment | Not described Receives: Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease
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 posted16 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJul 2014
Why it stopped: Corporate decision to spend money on other development programs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chlamydia InfectionsStudies 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
- Prospective
- Enrolment
- 1,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gen-Probe, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renee Wait, Study director, Gen-Probe, Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728103
- Sponsor's protocol ID
- ATVTS-US12-001
- Other IDs
- AC2PS-US12-002, ATVPS-US12-001, ATVTS-US12-003
- Status last verified
- Aug 2017
- First submitted
- 12 Nov 2012
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays
- ClinicalTrials.gov ID
- NCT01728103
- Acronym / sponsor ID
- ATVTS-US12-001
- Conditions
- Chlamydia Infections, Gonorrhea, Trichomonas Infections
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Corporate decision to spend money on other development programs.
- Enrolment
- 1,336 participants (actual)
- Lead sponsor
- Gen-Probe, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 16 Nov 2012 (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 obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Treatment | – | Device: APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.
Key inclusion criteria (7 listed)
- The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/vaginal intercourse within the past 12 months)
- 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 institutional review board [IRB]-approved waiver for parental consent for minors)
- The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
- Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
- Subject is asymptomatic and undergoing screening evaluation for possible STIs
Key exclusion criteria (4 listed)
- The subject took antibiotic medications within the last 21 days
- Subject already participated in this study
- Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
- Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
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® Trichomonas vaginalis & APTIMA® COMBO 2® AssaysIn Vitro Diagnostic Assays | Device | No Treatment |
Primary outcome
Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease
Time frame: approximately one year
Results and safety
The study was stopped early (reason given: Corporate decision to spend money on other development programs.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
Related trials for Chlamydia Infections
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
Not yet recruitingPhase 3
A Clinical Study to Assess the Efficacy of Weekly Doxycycline Prophylaxis to Reduce Bacterial Sexually Transmitted Infections (STI) in Young African Women
Sexually Transmitted Infection (STI), Gonorrhea
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.
Renee Wait study director
Gen-Probe, Incorporated
14 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 Infections and Gonorrhea, run by Gen-Probe, Incorporated at 14 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 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: stopped early, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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: Corporate decision to spend money on other development programs.). 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?
Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease (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 16 Aug 2017.