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Neonatal Sepsis and GBS Carriage Study

NCT00861055 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 849

Last updated 2024-05-08

No results posted yet for this study

Summary

In the proposed study, the investigators plan to establish the burden of early onset (EO) neonatal sepsis in the newborn population born at Maela Refugee Camp over a two year period.

Aims

1. Define the contribution of Group B streptococcus(GBS) to this problem by establishing:

* The prevalence of maternal GBS carriage
* The prevalence of culture positive and culture negative EO GBS sepsis
* The perinatal risk factors for EO GBS cases
2. Through these data assess the potential for intrapartum antibiotic prophylaxis using different strategies for reducing the burden of neonatal sepsis in this setting
3. To define the serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
4. To evaluate the prevalence of serum antibodies to common GBS capsular serotypes in pregnant women in this population, the influence of carriage on serotype (ST)-specific antibody and the ST-specific antibody concentrations in the mothers of cases of confirmed and clinical GBS disease.

Conditions

  • Neonatal Sepsis

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Francois Nosten, MD · Shoklo Malaria Research Unit

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861055 on ClinicalTrials.gov