Biological Markers for the Diagnosis of Central Nervous System Infective Diseases

Infection Clinical Trial

Official title:

Diagnosis Value of Procalcitonin, Interleukin-6, AgiotensininⅡin the Cerebrospinal Fluid of Patients With Central Nervous System Infective Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02278016
• Other study ID #: xijing-120
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2014
• Last updated: December 31, 2015
• Start date: August 2014
• Est. completion date: July 2017

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: jiang wen, MD
• Phone: 029-84771319
• Email: jiangwen[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
China	Xijing Hospital	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of procalcitonin, interleukin-6, agiotensinin? 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	No