Status:
UNKNOWN
Serocorrelate of Protection Against GBS (PREPARE WP3)
Lead Sponsor:
St George's, University of London
Collaborating Sponsors:
MU-JHU CARE
MRC/UVRI and LSHTM Uganda Research Unit
Conditions:
Group B Streptococcus Carrier in Childbirth
Group B Streptococcal Infection, Late-Onset
Eligibility:
All Genders
Up to 90 years
Brief Summary
A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, th...
Detailed Description
Group B Streptococcus (GBS) causes severe infections in young infants across the world. In 2015 it was estimated that there were at least 319,000 infants under three months of age with GBS disease wor...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Cases:
- Infant 0-90 days of life with GBS identified from a normally sterile site.
- Controls:
- Healthy infant born to a GBS colonised woman that does not develop GBS disease between birth and 90 days of life.
- Exclusion Criteria An infant is not eligible unless a parent/person with parental responsibility gives informed consent.
Exclusion
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04732026
Start Date
April 1 2020
End Date
April 1 2024
Last Update
October 26 2023
Active Locations (6)
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1
Assistance Publique Hopitaux de Paris (AP-HP)
Paris, France
2
Azienda Ospedaliero-Universitaria di Modena (AOU)
Modena, Italy
3
Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri,
Blantyre, Malawi
4
Academisch Medisch Centrum,Universiteit van Amsterdam
Amsterdam, Netherlands