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

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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

Tracking Information
First Submitted Date June 13, 2016
First Posted Date June 24, 2016
Last Update Posted Date June 24, 2016
Study Start Date May 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2016)
  • Incidence of group B streptococcal (GBS) disease [ Time Frame: From birth to 3 months of age ]
  • Case Fatality Rate of GBS disease [ Time Frame: From birth to 3 months of age ]
  • GBS serotype distribution [ Time Frame: From birth to 3 months of age ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China
Official Title Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population infants <3 months old born in or treated in a study hospital
Condition Invasive Group B Streptococcal Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Ji W, Liu H, Jin Z, Wang A, Mu X, Qin X, Wang W, Gao C, Zhu Y, Feng X, Lei J, She S, Jiang L, Liu J, Yang S, Liu Z, Li G, Li Q, Guo D, Aziz MM, Gillani AH, Fang Y. Disease burden and antimicrobial resistance of invasive group B streptococcus among infants in China: a protocol for a national prospective observational study. BMC Infect Dis. 2017 May 31;17(1):377. doi: 10.1186/s12879-017-2475-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 21, 2016)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages up to 90 Days   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02812576
Other Study ID Numbers XJTU-CDSP_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Haiying Liu, Guangzhou Women and Children's Medical Center
Study Sponsor Health Science Center of Xi'an Jiaotong University
Collaborators Guangzhou Women and Children's Medical Center
Investigators
Principal Investigator: Haiying Liu, MD, Ph.D Guangzhou Women and Children's Medical Center
PRS Account Health Science Center of Xi'an Jiaotong University
Verification Date June 2016