The Clinical and Molecular Epidemiology of Streptococcus... | NCT01757041

Studies
The Clinical and Molecular Epidemiology of Streptococcus Agalactiae Colonisation on the Kenyan Coast

NCT01757041

Sponsor

University of Oxford

Status

Completed

Last Update Posted

Dec 19, 2014Estimated

Enrollment

7,967Actual

Phase

Not provided

Conditions

Streptococcus Agalactiae (Streptococcus Group B)

Interventions

Not provided

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Nov 28, 2012

First Submission Date that Met QC Criteria

Dec 20, 2012

First Posted Date

Dec 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2014

Last Update Posted Date

Dec 19, 2014Estimated

Name	Class
Wellcome Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide. Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal sepsis (EOS, in <7 days of life) in sSA. In other regions, maternal carriage is associated with early onset neonatal sepsis, but in addition, other adverse perinatal outcomes (stillbirths, early neonatal death, low birth weight and prematurity). Robust data on maternal GBS carriage in sSA and its burden on adverse perinatal outcomes are lacking, with important consequences for public health interventions.

Through investigation of maternal carriage and perinatal outcomes at three different sites: rural, semi-rural and urban, this study will provide a comprehensive description of the burden of GBS in coastal Kenya, informing public health policy and driving forward interventions. Risk factors for maternal colonisation and invasive neonatal disease will be assessed, including through retrospective immunological investigation of cord blood in neonates subsequently identified as having invasive GBS disease or other adverse perinatal outcomes, compared to those without.

GBS isolates from maternal colonisation will be typed (sero-typing and molecular analysis), and these isolates will be compared to existing archived neonatal isolates from investigation of neonatal sepsis in KDH (Kilifi District Hospital). This is important so that we know the prevalent sub-types causing neonatal disease in Kenya, those which are carried by mothers, and therefore whether maternal GBS carriage correlates with a high risk of perinatal disease. GBS vaccines in development are type-specific and this will inform their use in sSA.

Stillbirths will also be investigated, in individual cases, through additional detailed microbiological and other laboratory investigations to make an assessment of the contribution of GBS to stillbirths in Kenya.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,967Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal recto-vaginal GBS colonisation	Prevalence of GBS recto-vaginal carriage in pregnant mothers in rural, semi-rural and urban sites.	Single time point (at delivery)

Secondary Outcomes

Measure	Description	Time Frame
Stillbirths	Association of stillbirth with Group B Streptococcus	Single time point (at delivery)
Neonatal GBS Colonisation	Prevalence of neonatal GBS colonization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted for delivery

Exclusion Criteria:

Consent refusal

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Mothers admitted for delivery to participating health centres (Kilifi District Hospital, Coast Provincial General Hospital, Bamba sub-District Hospital, Ganze Health Facility).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Seale, BMBCh	KEMRI-Wellcome Trust and University of Oxford	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bamba sub-District Hospital		Bamba	Coast		Kenya
Ganze Health Facility