Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
700 participants
OBSERVATIONAL
2014-03-01
2014-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Specimen Collection
illumigene CT and NG assays, illumipro-10
Interventions
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illumigene CT and NG assays, illumipro-10
Eligibility Criteria
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Inclusion Criteria
2. Any ethnicity or race
3. Subject \>14 and \<89 years of age
4. Subject who voluntarily gives written informed consent; not applicable for leftover specimens
5. Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG
6. Leftover urine specimens
Exclusion Criteria
2. Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens
3. Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens
4. Individuals who have been on antibiotic medications within 10 days.
5. Multiple sets of specimens from the same subject at different office visits
6. Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert.
7. Frozen archived specimens
14 Years
89 Years
ALL
Yes
Sponsors
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Meridian Bioscience, Inc.
INDUSTRY
Responsible Party
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Locations
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Planned Parenthood of the Rocky Mountains
Aurora, Colorado, United States
New England Center for Clinical Research
Fall River, Massachusetts, United States
Planned Parenthood Southeastern PA
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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Meridian Bioscience, Inc.
Identifier Type: OTHER
Identifier Source: secondary_id
MBI-01-CTNG
Identifier Type: -
Identifier Source: org_study_id