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Development and Optimization of a GBS Diagnostic Test

NCT00322829 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 269

Last updated 2019-02-28

No results posted yet for this study

Summary

The purpose of this clinical study is to develop an easily performed test to detect Group B Streptococcus (GBS) in pregnant women at the time of delivery, which would allow health care providers to make an accurate and rapid decision regarding the administration of antibiotics. Administering antibiotics during delivery reduces significantly the likelihood of transmission of GBS, a bacterium that can cause severe life-threatening disease in newborns. Three hundred and twenty pregnant females between 18 to 44 years of age, who are admitted for delivery at the time of consent, will be recruited at the Centre Hospitalier Universitaire de Quebec. Participation involves being observed for 30 minutes. The research nurse will obtain 2 vaginal/anal samples using standard techniques. One sample will be used to detect GBS with the approved BD GeneOhm StrepB assay and the other sample will be used for the development of the new point-of-care rapid detection GBS test.

Conditions

  • Streptococcus Group B

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Laval University

    lead OTHER

Principal Investigators

  • Michel G Bergeron, MD · Laval University

  • Fran Rubin, PhD · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322829 on ClinicalTrials.gov