Detection of Chlamydia (CT) and Gonorrhea (NG) | NCT02055742

Studies
Detection of Chlamydia (CT) and Gonorrhea (NG)

NCT02055742

Sponsor

Meridian Bioscience, Inc.

Status

Completed

Last Update Posted

Dec 7, 2017Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Chlamydia
Gonorrhea

Interventions

illumigene CT and NG assays, illumipro-10

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Meridian Bioscience, Inc.	Other Identifier	Meridian Bioscience, Inc.

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2014

Primary Completion Date

Sep 9, 2014Actual

Completion Date

Sep 9, 2014Actual

First Submitted Date

Jan 31, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2017

Last Update Posted Date

Dec 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

700Estimated

Label	Type	Description	Intervention Names
Specimen Collection			Device: illumigene CT and NG assays, illumipro-10

Name	Type	Description	Arm Group Labels	Other Names
illumigene CT and NG assays, illumipro-10	Device		Specimen Collection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Up to 60 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

89 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Symptomatic and asymptomatic subjects at least 14 years of age

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood of the Rocky Mountains		Aurora	Colorado	80012	United States
New England Center for Clinical Research

Condition Browse Module

MeSH Terms

ID	Term
D002690	Chlamydia Infections
D006069	Gonorrhea

Ancestor Terms

ID	Term
D002694	Chlamydiaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided