Development and Optimization of a GBS Diagnostic Test

February 26, 2019 updated by: Michel G. Bergeron, MD FRCPC, Laval University

Development and Optimization of a GBS Micro Total Analysis System (µTAS) Prototype for the Direct Detection of Group B Streptococci in Vaginal/Anal Specimens From Intrapartum Maternity Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Group B Streptococcus (GBS), also known as Streptococcus agalactiae, is a gram-positive diplococcus originally known for causing bovine mastitis and was not demonstrated to be a human pathogen until 1938. In the 1970s, GBS emerged as the leading cause of neonatal morbidity and mortality. GBS causes severe invasive disease in newborns. Approximately 80% of infections in young infants occur within the first week of life and are thus designated as early-onset disease. Late-onset infections usually occur in infants between 1 week and 3 months of age. Young infants with invasive GBS disease usually have sepsis or pneumonia but may, though less frequently, present with meningitis, osteomyelitis, or septic arthritis. Bloodstream infections, with or without pneumonia, are the main manifestation of neonatal GBS disease and are observed in approximately 90% of cases, while meningitis occurs in around 10%. Most early-onset disease results from ascending spread of GBS into the amniotic fluid, which leads to neonatal colonization and to invasive disease in some infants. Perinatal transmission of the organism can occur through both ruptured and intact membranes. Transmission from mother to child has been reported to be 29 times higher in GBS-colonized mothers than in noncolonized mothers. The new Centers for Disease Control and Prevention guidelines recommend universal prenatal culture-based screening for GBS colonization in all pregnant women. A more sensitive rapid-screening test for GBS that could accurately detect women who carry GBS at the time of delivery would obviate the need for prenatal screening while reducing the risk associated with the use of intrapartum prophylaxis with antibotics in non-colonized women. The main objective of the study is to develop and optimize a micro TAS prototype for rapid GBS detection directly from vaginal/anal specimens using swabs collected from pregnant women admitted for delivery. It is expected that this diagnostic system can replace the current "gold standard" which is microbiological culture in selective media for determining GBS colonization. Specific objectives of this study include: (1) analytical sensitivity of the micro TAS prototype (number of GBS colony forming units detected per vaginal/anal specimen) will be determined by using prospectively collected vaginal/anal specimens positive for GBS as well as negative vaginal/anal specimens that will be spiked with various numbers of GBS cells; (2) specificity of the micro TAS prototype (ability to detect specifically GBS nucleotide sequences without detecting other microbial species or human sequences) will be determined by using GBS-negative vaginal/anal specimens and; (3) sample analysis and performance of the micro TAS prototype will be compared to clinical samples with FDA-approved BD GeneOhm StrepB assay . Study participants will include 320 pregnant females between 18 to 44 years of age, who are admitted to the Centre Hospitalier Universitaire de Québec for delivery. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
269

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

  • Canada
      • Quebec City, Canada, G1V 4G2
        • Centre Hospitalier de l'Université Laval/ CHUQ

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women admitted for delivery at the Centre Hospitalier Universitaire de Québec (CHUQ)

Description

Inclusion Criteria:

  1. Be admitted for delivery
  2. Be able to provide written informed consent

Exclusion Criteria:

  1. Have vaginal bleeding
  2. Presence of placenta previa
  3. Have urgent indication to proceed to immediate delivery
  4. Have any condition which in the opinion of the investigator would impose a health risk to the subject or interfere with the evaluation of the GBS diagnostic

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel G Bergeron, MD, Laval University
  • Study Director: Fran Rubin, PhD, National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2006

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 05-0107

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.

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