Serosurveillance Study of Maternally Derived Anti-GBS Antibody

Group B Strep Infection Clinical Trial

— ProGreSs  

Official title:

Seroepidemiology of Maternally-derived Antibody Against Group B Streptococcus (GBS) in Mulago/Kawempe Hospitals Uganda

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04549220
• Other study ID #: 17.0018
• Status: Active, not recruiting
• Start date: April 24, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2020
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period. In 2014, neonatal deaths accounted for 44% of all deaths in children under 5 with neonatal infection accounting for over a third of all deaths. Group B Streptococcus (GBS) is a major cause of septicemia and meningitis in infants globally and a cause of severe adverse neurodevelopmental outcomes in up to 50% of meningitis survivors. It can also lead to sepsis in pregnant women. GBS acquisition occurs through vertical transmission in 15%-50% of infants born to a vaginally/rectally colonized mother. Maternal colonization is a prerequisite for early onset (EO) and a risk factor for late onset (LO) disease. Our proposal will provide these critical data in Uganda (a country with high neonatal disease burden) in a 12 month pilot study to determine: the burden of GBS disease in a cohort of mother/infant pairs and establish an active surveillance platform for monitoring of early and late onset neonatal infection in term and preterm infants in Uganda and compare this to the burden known for other African countries. This provides essential data on GBS disease outcomes from a high-HIV burden African cohort reflecting the usual standard of care in a low income, highly deprived urban environment. This pilot study will establish minimum disease estimates in the Ugandan cohort to determine the feasibility of a cohort study over three years to determine the level of antibody against GBS in cord blood from pregnancies where women are GBS colonized and non-colonized but whose infants do not develop GBS disease in the first three months of life and compare this to the level in the blood of infants who develop GBS disease. We will compare these results with those from other African countries such as South Africa to enable a robust estimate of potential sero-correlates of protection from natural infection against the most common GBS-disease-causing serotypes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: September 30, 2022
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years and older

Eligibility

Delivery (Birth) Cohort

Inclusion Criteria:

• consecutive mothers greater than or equal (=) the age of 18 years delivering at Kawempe Hospital (live or stillbirth) and emancipated minors aged between 14-17 years of age,
• willing to stay in the area for the first three months of life or willing to travel to clinic until their child is 2 years old if their infant has known or presumed GBS infection).

Exclusion Criteria:

• Unable to give written informed consent Active Surveillance Cohort Matching & Adjustment Criteria: (these will be applied at the analysis stage): (i) exposure to intrapartum antibiotic prophylaxis: defined as intravenous penicillin, ampicillin, cefazolin, clindamycin or vancomycin, for =2 hours before delivery. (ii) blood transfusion in the 30 days before delivery (iii) HIV status (iv) Maternal age (v) Infant gestational age

Related Conditions & MeSH terms

• Communicable Diseases
• Group B Strep Infection
• Group B Streptococcal Infection, Early-Onset
• Group B Streptococcal Infection, Late-Onset
• Group B Streptococcus Carrier in Childbirth
• Group B Streptococcus Neonatal Sepsis
• Infection
• Neonatal Sepsis
• Streptococcal Infections

Locations

Country	Name	City	State
Uganda	MUJHU Care Ltd	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
St George's, University of London	MRC/UVRI Uganda Research Unit on Aids, MU-JHU CARE

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal anti-GBS antibody concentration in infants with GBS disease compared to healthy controls.	To establish maternal anti-GBS antibody concentration in infants with GBS disease compared to healthy controls.	31 October 2020
Secondary	Health-centre level active surveillance	To establish health-centre level active surveillance for neonatal sepsis and meningitis and GBS-related stillbirths.	31 October 2020
Secondary	Neurodevelopmental outcomes	To establish the neurodevelopmental outcomes of infants with GBS disease in Uganda up to 2 years of age.	31 October 2020
Secondary	GBS colonisation	To determine the GBS colonisation rate and serotypes in Ugandan women at delivery	31 October 2020