Invasive Group B Streptococcal DiseaseNCT02812576
Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China
An observational study of Invasive Group B Streptococcal Disease, run by Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Invasive Group B Streptococcal Disease
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 days
- All sexes
- No healthy volunteers
- Child
Study population: infants <3 months old born in or treated in a study hospital
Who may be able to join
- Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid.
- ≤90 days old at the time of GBS confirmation.
- Voluntary written informed consent provided.
Who cannot join
- 1. None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Health Science Center of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Wenjing Ji, MS, 86＋29＋82655132, yfyx_8312@163.com
Yu Fang, Ph.D, 86＋29＋82655132, yufang@mail.xjtu.edu.cn
About this study
Official title: Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study
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.
- Conditions
- Invasive Group B Streptococcal Disease
- Keywords
- Group B streptococcus, Infants, China
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of group B streptococcal (GBS) disease
Measured: From birth to 3 months of age
Case Fatality Rate of GBS disease
Measured: From birth to 3 months of age
GBS serotype distribution
Measured: From birth to 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invasive Group B Streptococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center
- Responsible party
- Principal investigator, Haiying Liu, Guangzhou Women and Children's Medical Center
- Investigators
- Haiying Liu, MD, Ph.D, Principal investigator, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812576
- Sponsor's protocol ID
- XJTU-CDSP_01
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38692955Ji 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.
PubMed 28569141
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02812576
- Acronym / sponsor ID
- XJTU-CDSP_01
- Conditions
- Invasive Group B Streptococcal Disease
- Keywords
- Group B streptococcus, Infants, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants <3 months old born in or treated in a study hospital
Key inclusion criteria (3 listed)
- Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid.
- ≤90 days old at the time of GBS confirmation.
- Voluntary written informed consent provided.
Key exclusion criteria (1 listed)
- 1. None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 38692955Ji 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.
- Derived from this study: PubMed 28569141Ji 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.
- Individual participant dataSharing planned: Undecided
Related trials for Invasive Group B Streptococcal Disease
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Not yet recruitingObservational study
Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
Invasive Group B Streptococcus Disease, Group B Streptococcus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiying Liu, MD, Ph.D principal investigator
Guangzhou Women and Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Group B Streptococcal Disease, run by Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjing Ji, MS (86＋29＋82655132, yfyx_8312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of group B streptococcal (GBS) disease (time frame: From birth to 3 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.