Status:
UNKNOWN
Developing a Controlled Human Infection Model for Group B Streptococcus (CHIM_GBS)
Lead Sponsor:
St George's, University of London
Conditions:
Group B Streptococcus
Eligibility:
FEMALE
18-40 years
Brief Summary
Group B Streptococcus (GBS) is the leading cause of neonatal sepsis and meningitis. In 2015, it was estimated that worldwide there were at least 320,000 infants with invasive GBS disease, 90,000 infan...
Detailed Description
The global burden of Group B Streptococcus (GBS) is high and represents an unmet public health need. GBS is the leading cause of neonatal sepsis and meningitis in most countries. In 2015, it was estim...
Eligibility Criteria
Inclusion
- Age 18-40
- Healthy
- Willing to comply with study protocol requirements
- Able to give informed consent
- Willing not to become pregnant and use adequate contraception for length of study
Exclusion
- Latex allergy
- Intra-Uterine Device/Intra-Uterine System
- Presence of untreated sexually transmitted infections at baseline
- Known Diabetes
- Genital dermatoses
- Diagnosis of Cervical Intraepithelial Neoplasia within past 3 years
- Current pregnancy
- Post-Menopausal
Key Trial Info
Start Date :
November 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04059510
Start Date
November 4 2019
End Date
November 1 2020
Last Update
February 13 2020
Active Locations (1)
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1
St George's, University of London
London, United Kingdom, SW17 0RE