Group B Streptococcus Carrier in ChildbirthProGreSsNCT04549220
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
An observational study of Group B Streptococcus Carrier in Childbirth and Group B Streptococcal Infection, Late-Onset, run by St George's, University of London at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 17 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset
- How many people
- 6,000 participants
- Where
- 1 siteUganda
- Study dates
- 24 Apr 2019to 30 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will enrol pregnant women from the general population who deliver at Kawempe Hospital and follow their infants to 90 days of age.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroepidemiology of Maternally-derived Antibody Against Group B Streptococcus (GBS) in Mulago/Kawempe Hospitals Uganda
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.
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis, Group B Strep Infection
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Delivery (Birth) Cohort | All women greater than or equal (≥) to 18 years of age and emancipated minors aged between 14 and 17 years of age delivering a live infant or stillbirth at Kawempe Referral Hospital over a 6-month pilot phase will be invited to participate in the study until a sample size of at least 5000-6000 women is achieved. | |
| Active Surveillance Cohort | This is expected to improve capacity for managing and investigating infants <3 months of age presenting with suspected sepsis at Kawempe Neonatal Intensive Care Unit (NICU), Postnatal Ward, and Acute Paediatric Wards and Mulago Hospital Paediatric Acute Care Unit, through provision of supplies for blood culture, CSF culture and nasopharyngeal swabs. Mothers/caretakers of Neonates that are diagnosed with GBS through this active case surveillance will be invited to participate in the study and will be enrolled following written informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 31 October 2020
Secondary outcomes (3)
Health-centre level active surveillance
To establish health-centre level active surveillance for neonatal sepsis and meningitis and GBS-related stillbirths.
Measured: 31 October 2020
Neurodevelopmental outcomes
To establish the neurodevelopmental outcomes of infants with GBS disease in Uganda up to 2 years of age.
Measured: 31 October 2020
GBS colonisation
To determine the GBS colonisation rate and serotypes in Ugandan women at delivery
Measured: 31 October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start24 Apr 2019
- Primary completion30 Apr 2021
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B Streptococcus Carrier in ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- MU-JHU CARE, MRC/UVRI and LSHTM Uganda Research Unit
- Responsible party
- Sponsor
- Investigators
- Kirsty Le Doare, Dr., Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549220
- Sponsor's protocol ID
- 17.0018
- Acronym
- ProGreSs
- Status last verified
- Jan 2025
- First submitted
- 8 Sep 2020
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroepidemiology of Maternally-derived Antibody Against Group B Streptococcus (GBS) in Mulago/Kawempe Hospitals Uganda
- ClinicalTrials.gov ID
- NCT04549220
- Acronym / sponsor ID
- ProGreSs / 17.0018
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis, Group B Strep Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- MU-JHU CARE, MRC/UVRI and LSHTM Uganda Research Unit
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delivery (Birth) Cohort | – | –All women greater than or equal (≥) to 18 years of age and emancipated minors aged between 14 and 17 years of age delivering a live infant or stillbirth at Kawempe Referral Hospital over a 6-month pilot phase will be invited to participate in the study until a sample size of at least 5000-6000 women is achieved. |
| Active Surveillance Cohort | – | –This is expected to improve capacity for managing and investigating infants <3 months of age presenting with suspected sepsis at Kawempe Neonatal Intensive Care Unit (NICU), Postnatal Ward, and Acute Paediatric Wards and Mulago Hospital Paediatric Acute Care Unit, through provision of supplies for blood culture, CSF culture and nasopharyngeal swabs. Mothers/caretakers of Neonates that are diagnosed with GBS through this active case surveillance will be invited to participate in the study and will be enrolled following written informed consent. |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will enrol pregnant women from the general population who deliver at Kawempe Hospital and follow their infants to 90 days of age.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal anti-GBS antibody concentration in infants with GBS disease compared to healthy controls.
Time frame: 31 October 2020
To establish maternal anti-GBS antibody concentration in infants with GBS disease compared to healthy controls.
3 secondary outcomes
Health-centre level active surveillance
Time frame: 31 October 2020
Neurodevelopmental outcomes
Time frame: 31 October 2020
GBS colonisation
Time frame: 31 October 2020
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Le Doare, Dr. principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group B Streptococcus Carrier in Childbirth and Group B Streptococcal Infection, Late-Onset, run by St George's, University of London at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal anti-GBS antibody concentration in infants with GBS disease compared to healthy controls. (time frame: 31 October 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.