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Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812576
Recruitment Status : Unknown
Verified June 2016 by Haiying Liu, Guangzhou Women and Children's Medical Center.
Recruitment status was:  Recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
Guangzhou Women and Children's Medical Center
Information provided by (Responsible Party):
Haiying Liu, Guangzhou Women and Children's Medical Center

Brief Summary:
Data on neonatal GBS disease are very limited in China. Acceptance and implementation of prevention measures such as antibiotics prevention or vaccination against GBS disease would require robust data. This study as the first national, multicenter study to investigate the epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to appraise the necessity of appropriate interventions.

Condition or disease
Invasive Group B Streptococcal Disease

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study
Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017



Primary Outcome Measures :
  1. Incidence of group B streptococcal (GBS) disease [ Time Frame: From birth to 3 months of age ]
  2. Case Fatality Rate of GBS disease [ Time Frame: From birth to 3 months of age ]
  3. GBS serotype distribution [ Time Frame: From birth to 3 months of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
infants <3 months old born in or treated in a study hospital
Criteria

Inclusion Criteria:

  1. Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid.
  2. ≤90 days old at the time of GBS confirmation.
  3. Voluntary written informed consent provided.

Exclusion Criteria:

1. None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812576


Contacts
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Contact: Wenjing Ji, MS 86+29+82655132 yfyx_8312@163.com
Contact: Yu Fang, Ph.D 86+29+82655132 yufang@mail.xjtu.edu.cn

Locations
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China, Shaanxi
Health Science Center of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Wenjing Ji, MS    86+29+82655132    yfyx_8312@163.com   
Contact: Yu Fang, Ph.D    86+29+82655132    yufang@mail.xjtu.edu.cn   
Sponsors and Collaborators
Health Science Center of Xi'an Jiaotong University
Guangzhou Women and Children's Medical Center
Investigators
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Principal Investigator: Haiying Liu, MD, Ph.D Guangzhou Women and Children's Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haiying Liu, Director of Clinical Laboratory, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT02812576    
Other Study ID Numbers: XJTU-CDSP_01
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Haiying Liu, Guangzhou Women and Children's Medical Center:
Group B streptococcus
Infants
China