NCT02278016

Brief Summary

Bacterial meningitis is a potentially life-threatening disease that is associated with substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve outcome and prevent antibiotic overuse. Here we try to explore new biological markers for the diagnosis of the central nervous system infection disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

October 27, 2014

Last Update Submit

December 31, 2015

Conditions

Infection

Keywords

procalcitonininterleukin-6agiotensininⅡ

Outcome Measures

Primary Outcomes (1)

  • Levels of procalcitonin, interleukin-6, agiotensininⅡ in the serum and cerebrospinal fluid

    meet the clinical diagnostic criteria for the central nervous system infection disease, the blood and cerebrospinal fluid samples after onset.

    36 months

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

More than 12 years old; meet the clinical diagnostic criteria for the central nervous system infection disease

You may qualify if:

  • Aged 13 years or older;
  • At least two of the following clinical characteristics:headache, fever, neck stiffness, mental symptoms or consciousness impairment or seizures
  • Patients' family signed informed consent.

You may not qualify if:

  • Contraindications to lumbar puncture
  • Patients with active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

  • Li W, Sun X, Yuan F, Gao Q, Ma Y, Jiang Y, Yang X, Yang F, Ma L, Jiang W. Diagnostic Accuracy of Cerebrospinal Fluid Procalcitonin in Bacterial Meningitis Patients with Empiric Antibiotic Pretreatment. J Clin Microbiol. 2017 Apr;55(4):1193-1204. doi: 10.1128/JCM.02018-16. Epub 2017 Feb 8.

    PMID: 28179405DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

procalcitonin,interleukin-6,agiotensininⅡ

MeSH Terms

Conditions

Infections

Study Officials

  • jiang wen, MD

    The Department of Neurology , Xijing Hospital

    STUDY CHAIR

Central Study Contacts

jiang wen, MD

CONTACT

029-84771319jiangwen@fmmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 29, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

January 1, 2016

Record last verified: 2015-12

Locations

CN(1)