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

NCT ID: NCT02812576

Last Updated: 2016-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Invasive Group B Streptococcal Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Haiying Liu

Director of Clinical Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haiying Liu, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

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Health Science Center of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjing Ji, MS

Role: CONTACT

86+29+82655132

Yu Fang, Ph.D

Role: CONTACT

86+29+82655132

Facility Contacts

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Wenjing Ji, MS

Role: primary

86+29+82655132

Yu Fang, Ph.D

Role: backup

86+29+82655132

References

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Ji W, Zhou H, Li J, Britto CD, Liu Z, Zhang W, Du J, Madhi SA, Kwatra G, Dangor Z, Jin Z, Zhao H, Zhao Y, Fang Y, Li J. Distributions of candidate vaccine Targets, virulence Factors, and resistance features of invasive group B Streptococcus using Whole-Genome Sequencing: A Multicenter, population-based surveillance study. Vaccine. 2024 Jun 11;42(16):3564-3571. doi: 10.1016/j.vaccine.2024.04.062. Epub 2024 Apr 30.

Reference Type DERIVED
PMID: 38692955 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28569141 (View on PubMed)

Other Identifiers

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XJTU-CDSP_01

Identifier Type: -

Identifier Source: org_study_id

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