- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00300534
Multi-site Study of Rapid Diagnostic Syphilis Assays
September 6, 2012 updated by: Centers for Disease Control and Prevention
Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States
- Los Angeles Department of Health Services
-
-
Georgia
-
Atlanta, Georgia, United States
- Fulton County Department of Health
-
-
Illinois
-
Chicago, Illinois, United States, 60616
- Chicago Department of Public Health
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Bell Flower Clinic
-
-
New York
-
New York City, New York, United States
- New York City Department of Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive patients
Exclusion Criteria:
- Less than age 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Abbott Laboratories Determine test for syphilis
Abbott Laboratories Determine rapid test for syphilis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnosis of Treponema pallidum infection
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert E. Johnson, MD, MPH, Centers for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Primary Completion (ACTUAL)
December 1, 2005
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
March 2, 2006
First Submitted That Met QC Criteria
March 2, 2006
First Posted (ESTIMATE)
March 9, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 7, 2012
Last Update Submitted That Met QC Criteria
September 6, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHSTP-2875
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Syphilis
-
Ottawa Hospital Research InstituteCIHR Canadian HIV Trials NetworkTerminatedSyphilis | Primary Syphilis | Secondary Syphilis | Early-Latent SyphilisCanada
-
Fundación FLS de Lucha Contra el Sida, las Enfermedades...RecruitingPrimary Syphilis | Secondary Syphilis | Early Latent SyphilisSpain, United Kingdom
-
Stanford UniversitySanta Clara Valley Medical CenterWithdrawnCongenital Syphilis | Maternal Syphilis During Pregnancy - Baby Not Yet DeliveredUnited States
-
Hospital de Niños R. Gutierrez de Buenos AiresCompleted
-
MedMira Laboratories Inc.Public Health Agency of Canada (PHAC)RecruitingSyphilis | Syphilis Infection | Early Syphilis, SymptomaticCanada
-
National Taiwan University HospitalChang Gung Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial... and other collaboratorsCompletedEarly Syphilis | Serologic Response of Syphilis | High Risk BehaviorTaiwan
-
Tulane University School of Public Health and Tropical...University of Zambia; Kinshasa School of Public Health; Instituto de Efectividad...CompletedCongenital SyphilisUnited States, Congo, The Democratic Republic of the, Argentina, Zambia
-
University Hospital, GenevaFonds national SuisseCompleted
-
National Taiwan University HospitalChina Medical University Hospital; Kaohsiung Medical University Chung-Ho Memorial... and other collaboratorsNot yet recruitingEarly Syphilis, Latent, Serological Relapse After Treatment
-
World Health OrganizationUnknown
Clinical Trials on Abbott Laboratories Determine test for syphilis
-
California State University, Long BeachNational Institute on Drug Abuse (NIDA)CompletedHepatitis B | Hepatitis C | HIV | SyphilisUnited States
-
Institut Investigacio Sanitaria Pere VirgiliInstitut Català d'Oncologia; Hospital Universitario Ramon y Cajal; Hospital Arnau... and other collaboratorsRecruitingMetastatic Colorectal Cancer | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastasis | Metastatic Prostate CancerSpain
-
Institut de Recherche en Sciences de la Sante,...African Population and Health Research Center; World Health OrganizationCompletedDiagnoses Disease | Syphilis Infection
-
Institut de Recherche pour le DeveloppementFoundation for Innovative New Diagnostics; Programme National de lutte contre... and other collaboratorsCompletedSleeping Sickness | Human African Trypanosomiasis | Trypanosoma Brucei Gambiense; Infection | West African Sleeping SicknessCôte D'Ivoire, Guinea