Multi-site Study of Rapid Diagnostic Syphilis Assays

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.

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Key information

Conditions

Syphilis Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Disease Genital Diseases Gram-Negative Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Treponemal Infections Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles Department of Health Services, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Consecutive patients

Exclusion criteria

Less than age 18 years

Treatment and study plan

Abbott Laboratories Determine test for syphilis

Device

Investigational syphilis immunochromatographic strip test

Device

Primary outcomes

Diagnosis of Treponema pallidum infection

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Official study title

Multi-site Study of Rapid Diagnostic Syphilis Assays of Persons Attending STD Clinics in High Syphilis Morbidity Areas

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2009
First posted: Mar 9, 2006
Registry last updated: Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed