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Neonatal Sepsis and GBS Carriage Study (NSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wellcome Trust
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00861055
First received: March 12, 2009
Last updated: January 22, 2010
Last verified: January 2010
  Purpose

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.

Condition
Neonatal Sepsis
Maternal GBS Carriage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical and Microbiological Study of Early Onset Neonatal Sepsis in Refugee Infants and Group B Streptococcal Carriage in Expectant Refugee Mothers Living on the Thai-Burmese Border

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Incidence of early onset neonatal sepsis (including the prevalence of culture positive and culture negative EO GBS sepsis) [ Time Frame: 7 days after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perinatal risk factors for early onset neonatal sepsis [ Time Frame: 7 days after delivery ] [ Designated as safety issue: No ]
  • Prevalence of maternal GBS carriage [ Time Frame: During labour ] [ Designated as safety issue: No ]
  • GBS serotype specific antibody prevalence [ Time Frame: During labour ] [ Designated as safety issue: No ]
  • serotypes and antibiotic susceptibility profile of carried and invasive GBS strains [ Time Frame: During labour ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants
Infants less than 7 days of age with clinical signs of sepsis
Mothers
Mothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation

Detailed Description:

Globally 4 million neonates die each year, the most common cause of death is sepsis. Causes of neonatal sepsis in low and middle income countries are reported to differ from those in the developed world. Gram negative organisms are thought to be more common. Despite group B streptococcus (GBS) carriage rates being apparently similar to the developed world, GBS sepsis is rarely reported in developing countries: our hypothesis is that GBS is an under recognized neonatal pathogen in the developing world. There are many possible explanations why GBS infection may be under reported including wider, less discriminating use of antibiotics in the period just before the onset of labour and inadequate microbiological diagnostic services.

The proposed study, to be conducted at Maela Refugee Camp Thailand, has two components, both being prospective descriptive cohort studies which will be run concurrently:

  1. Contribution of GBS to early onset neonatal sepsis at Maela refugee camp
  2. GBS carriage, seroepidemiology and GBS antibody study. Infants with neonatal sepsis will be identified clinically. They will be assessed and, after informed consent is taken from their mother, they will have a full septic screen including a complete blood count, serum C-reactive protein, blood culture, lumbar puncture and a deep swab taken from their ear canal. If the ear swab is positive for GBS, and the blood culture is negative for other pathogens, a presumptive diagnosis of EO GBS sepsis will be made. The mother will have 5ml blood sample for GBS serotype-specific antibody testing and a vaginal rectal swab obtained (if this has not been performed already).

Women who consent to take part in the GBS carriage study will, during labour, have a low vaginal and rectal swab taken which will be processed using the CDC Group B streptococcus guideline. Additionally, a GBS-specific PCR of the swab will be used to identify culture-negative cases of GBS carriage. 5ml of venous blood will be taken from the mother and 5ml of blood taken, after delivery, from the placenta (from the umbilical vein) for GBS antibody studies.

This study will establish the burden of clinical early onset neonatal sepsis in our population. Additionally this study will establish the prevalence of maternal GBS carriage and assess the potential for intrapartum antibiotic prophylaxis for reducing the burden of neonatal sepsis in this setting. It will also define the serotypes and antibiotic susceptibility profile of carried and invasive GBS strains.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All expectant mothers who follow ANC care at SMRU Maela Refugee Camp and their infants.

Criteria

Part 1. The contribution of GBS to EO neonatal sepsis at Maela Refugee Camp study

  1. Infants, < 7 days of age, who are born to mothers who followed antenatal care at SMRU antenatal clinic, Maela Refugee Camp and have a clinical diagnosis of sepsis
  2. Written informed consent from the mother

Exclusion criteria:

  1. Severe congenital abnormality identified prenatally or at birth
  2. Infants less than 28 weeks gestation Part 2. The GBS carriage, seroepidemiology and GBS antibody study

Inclusion criteria:

  1. Mothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation
  2. Written informed consent from the mother

Exclusion criteria:

1. Mothers receiving antibiotics at the time of sampling

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861055

Contacts
Contact: Francois Nosten, MD francois@tropmedres.ac
Contact: Claudia Turner, MD claudiaturner@doctors.org.uk

Locations
Thailand
Shoklo Malaria Research Unit Recruiting
MaeSod, Tak, Thailand, 63110
Contact: Francois Nosten, MD       francois@shoklo-unit.com   
Contact: Phaikyeong Cheah, PhD       phaikyeong@tropmedres.ac   
Sub-Investigator: Claudia Turner, MD         
Sub-Investigator: Paul Turner, MD         
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Investigators
Principal Investigator: Francois Nosten, MD Shoklo Malaria Research Unit
  More Information

No publications provided

Responsible Party: Professor Francois Nosten, Shoklo Malaria Research Unit
ClinicalTrials.gov Identifier: NCT00861055     History of Changes
Other Study ID Numbers: SMRU0901
Study First Received: March 12, 2009
Last Updated: January 22, 2010
Health Authority: Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 23, 2014