NCT04732026

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, the Netherlands, Italy and France), with 3:1 (450) serotype matched healthy controls.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
6 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3.9 years

First QC Date

January 26, 2021

Last Update Submit

October 24, 2023

Conditions

Group B Streptococcus Carrier in ChildbirthGroup B Streptococcal Infection, Late-OnsetGroup B Streptococcal Infection, Early-OnsetGroup B Streptococcus Neonatal SepsisGroup B Strep Infection

Outcome Measures

Primary Outcomes (1)

  • To establish a biobank of at least 150 GBS serotype III cases including both the isolate and associated maternal and infant serum.

    Biobank at St George's, University of London

    Over the course of 2 years

Secondary Outcomes (5)

  • To determine the quantity of antibody associated with protection against GBS disease

    Over the course of 2 years

  • To determine the functional antibody associated with protection against GBS disease.

    Over the course of 2 years

  • To demonstrate the relationship between antibody quantity and function in protection against GBS disease

    Over the course of 2 years

  • To refine estimates for serocorrelates of protection against GBS disease.

    Over the course of 2 years

  • To provide training to participating African laboratories to assure the quality of sample collection and data curation.

    Over the course of 2 years

Study Arms (2)

Cases

150 infants with invasive serotype III GBS disease (isolation of GBS from a normally sterile site, i.e. blood or CSF) in the first 90 days of life from six countries (Malawi, Uganda, UK, the Netherlands, Italy and France).

Controls

450 infants exposed to serotype III GBS at birth - but who do not develop invasive GBS disease in the first 90 days of life from six countries (Malawi, Uganda, UK, the Netherlands, Italy and France).

Eligibility Criteria

AgeUp to 90 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study will enroll infant subjects from the general population who are delivered at one of the six hospital sites.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Assistance Publique Hopitaux de Paris (AP-HP)

Paris, France

RECRUITING

Azienda Ospedaliero-Universitaria di Modena (AOU)

Modena, Italy

RECRUITING

Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri,

Blantyre, Malawi

RECRUITING

Academisch Medisch Centrum,Universiteit van Amsterdam

Amsterdam, Netherlands

RECRUITING

MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd

Kampala, Uganda

RECRUITING

St George's, University of London

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord blood - target volume 5mls, minimum 1.5mls Maternal serum- target volume 5mls, minimum 1.5mls Infant serum - target volume 2mls, minimum based on infant birthweight Bacterial Isolates - GBS isolates from blood or CSF of infants with invasive GBS disease

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Kirsty Le Doare, Prof

    St George's, University of London

    PRINCIPAL INVESTIGATOR

  • Stephen Cose, Dr

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Davies, Dr

CONTACT

+442087255214hdavies@sgul.ac.uk

Madeleine Cochet

CONTACT

+442087255214mcochet@sgul.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 1, 2021

Study Start

April 1, 2020

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)UG(1)MA(1)GB(1)NL(1)FR(1)