Multi-site Study of Rapid Diagnostic Syphilis Assays

NCT ID: NCT00300534

Last Updated: 2012-09-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2009-07-31

Brief Summary

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The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (investigational test only) and whole blood, plasma, and serum by venipuncture.

Detailed Description

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Conditions

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Syphilis

Keywords

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Diagnosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Abbott Laboratories Determine test for syphilis

Abbott Laboratories Determine rapid test for syphilis

Group Type NO_INTERVENTION

Abbott Laboratories Determine test for syphilis

Intervention Type DEVICE

Investigational syphilis immunochromatographic strip test

Intervention Type DEVICE

Interventions

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Abbott Laboratories Determine test for syphilis

Intervention Type DEVICE

Investigational syphilis immunochromatographic strip test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients

Exclusion Criteria

* Less than age 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert E. Johnson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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Los Angeles Department of Health Services

Los Angeles, California, United States

Site Status

Fulton County Department of Health

Atlanta, Georgia, United States

Site Status

Chicago Department of Public Health

Chicago, Illinois, United States

Site Status

Bell Flower Clinic

Indianapolis, Indiana, United States

Site Status

New York City Department of Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CDC-NCHSTP-2875

Identifier Type: -

Identifier Source: org_study_id