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Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795975
Recruitment Status : Terminated (Sponsor business decision)
First Posted : June 10, 2016
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.

Brief Summary:
The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.

Condition or disease
Chlamydia Trachomatis Gonorrhea

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Study Type : Observational
Actual Enrollment : 1766 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Sensitivity and specificity [ Time Frame: Enrollment ongoing until estimated March 2017 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795975


Locations
Show Show 18 study locations
Sponsors and Collaborators
Hologic, Inc.
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Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT02795975    
Other Study ID Numbers: A10417-AC2PS-CSP-02
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gonorrhea
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Neisseriaceae Infections