ChlamydiaNCT02055742
Detection of Chlamydia (CT) and Gonorrhea (NG)
An observational study of Chlamydia and Gonorrhea, run by Meridian Bioscience, Inc. at 3 sites in United States.
Trial summary
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations. Read more about this study
- Who is it for?
- Ages 14 to 89 yearsHealthy volunteers can take part
- What is being tested?
- illumigene CT and NG assays, illumipro-10
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2014to 9 Sep 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 14 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Symptomatic and asymptomatic subjects at least 14 years of age
Who may be able to join
- Male or female
- Any ethnicity or race
- Subject >14 and <89 years of age
- Subject who voluntarily gives written informed consent; not applicable for leftover specimens
- Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
- Leftover urine specimens
Who cannot join
- Subjects < 14 or >90 years of age
- Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
- Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
- Individuals who have been on antibiotic medications within 10 days.
- Multiple sets of specimens from the same subject at different office visits
- Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.
- Frozen archived specimens
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Planned Parenthood of the Rocky Mountains
Aurora, Colorado, 80012
New England Center for Clinical Research
Fall River, Massachusetts, 02720
Planned Parenthood Southeastern PA
Philadelphia, Pennsylvania, 19107
About this study
Official title: Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.
- Being tested
- illumigene CT and NG assays, illumipro-10
- Medical subject headings
- Chlamydia Infections, Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
illumigene CT and NG assays, illumipro-10Device
| Study group | Role | What they receive |
|---|---|---|
| Specimen Collection | Not described Receives: Device: illumigene CT and NG assays, illumipro-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
Testing of each set of subject samples is completed within 60 days of sample collection
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start1 Mar 2014
- Primary completion9 Sep 2014
- Study completion9 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlamydiaStudies 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055742
- Sponsor's protocol ID
- MBI-01-CTNG
- Other IDs
- Meridian Bioscience, Inc.
- Status last verified
- Sep 2014
- First submitted
- 31 Jan 2014
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
- ClinicalTrials.gov ID
- NCT02055742
- Acronym / sponsor ID
- MBI-01-CTNG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2014
- Primary completion
- 9 Sep 2014 (actual)
- Study completion
- 9 Sep 2014 (actual)
- First posted
- 5 Feb 2014 (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.
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen Collection | – | Device: illumigene CT and NG assays, illumipro-10 |
Who may qualify
- Ages
- 14 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Symptomatic and asymptomatic subjects at least 14 years of age
Key inclusion criteria (6 listed)
- Male or female
- Any ethnicity or race
- Subject >14 and <89 years of age
- Subject who voluntarily gives written informed consent; not applicable for leftover specimens
- Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
Key exclusion criteria (7 listed)
- Subjects < 14 or >90 years of age
- Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
- Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
- Individuals who have been on antibiotic medications within 10 days.
- Multiple sets of specimens from the same subject at different office visits
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 |
|---|---|---|
| illumigene CT and NG assays, illumipro-10 | Device | Specimen Collection |
Primary outcome
Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease
Time frame: Up to 60 days
Testing of each set of subject samples is completed within 60 days of sample collection
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 7 Dec 2017.
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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.
3 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 and Gonorrhea, run by Meridian Bioscience, Inc. at 3 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 6 inclusion and 7 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 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease (time frame: Up to 60 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 7 Dec 2017.