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Biological Markers for the Diagnosis of Central Nervous System Infective Diseases

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ClinicalTrials.gov Identifier: NCT02278016
Recruitment Status : Unknown
Verified December 2015 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease
Infection

Detailed Description:
To investigate the diagnosis value of procalcitonin,interleukin-6, agiotensininⅡin the cerebrospinal fluid in the central nervous system infection disease.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Diagnosis Value of Procalcitonin, Interleukin-6, AgiotensininⅡin the Cerebrospinal Fluid of Patients With Central Nervous System Infective Diseases
Study Start Date : August 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2017



Primary Outcome Measures :
  1. Levels of procalcitonin, interleukin-6, agiotensininⅡ in the serum and cerebrospinal fluid [ Time Frame: 36 months ]
    meet the clinical diagnostic criteria for the central nervous system infection disease, the blood and cerebrospinal fluid samples after onset.


Biospecimen Retention:   Samples Without DNA
procalcitonin,interleukin-6,agiotensininⅡ


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
More than 12 years old; meet the clinical diagnostic criteria for the central nervous system infection disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Contraindications to lumbar puncture
  2. Patients with active malignancy

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): NCT02278016


Contacts
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Contact: jiang wen, MD 029-84771319 jiangwen@fmmu.edu.cn

Locations
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China, Shaanxi
Xijing Hospital Recruiting
Xian, Shaanxi, China, 710032
Contact: jiang wen, MD    029-84771319    jiangwen@fmmu.edu.cn   
Principal Investigator: jiang wen, MD         
Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Chair: jiang wen, MD The Department of Neurology , Xijing Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02278016    
Other Study ID Numbers: xijing-120
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by Xijing Hospital:
procalcitonin
interleukin-6
agiotensininⅡ