NCT00300534

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

March 2, 2006

Last Update Submit

September 6, 2012

Conditions

Syphilis

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Treponema pallidum infection

    7 days

Study Arms (1)

Abbott Laboratories Determine test for syphilis

NO INTERVENTION

Abbott Laboratories Determine rapid test for syphilis

Device: Abbott Laboratories Determine test for syphilisDevice: Investigational syphilis immunochromatographic strip test

Interventions

Abbott Laboratories Determine test for syphilisDEVICE
Abbott Laboratories Determine test for syphilis
Investigational syphilis immunochromatographic strip testDEVICE
Abbott Laboratories Determine test for syphilis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients

You may not qualify if:

  • Less than age 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Los Angeles Department of Health Services

Los Angeles, California, United States

Location

Fulton County Department of Health

Atlanta, Georgia, United States

Location

Chicago Department of Public Health

Chicago, Illinois, 60616, United States

Location

Bell Flower Clinic

Indianapolis, Indiana, 46202, United States

Location

New York City Department of Health

New York, New York, United States

Location

MeSH Terms

Conditions

SyphilisDisease

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert E. Johnson, MD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 9, 2006

Study Start

August 1, 2002

Primary Completion

December 1, 2005

Study Completion

July 1, 2009

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

US(5)