Bacterial Meningitis Clinical Trial
Official title:
Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis
Verified date | May 2015 |
Source | Beijing Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Observational |
The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | June 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 18 Years |
Eligibility |
Inclusion Criteria: - Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 °C rectal or 38.0 °C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following: A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl) - Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis Exclusion Criteria: - Congenital immunodeficiency patients - HIV patients - Patients with corticosteroid treatment for long time - Patients with disorders in adrenal gland and pituitary gland and hypothalamus - Patients with tuberculosis |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gang Liu |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | vitamin d level change | Serum vitamin d level will be detected in the first day of hospitalization and twenty-eighth day of hospitalization, no vitamin d supplementation during this time | change in serum vitamin d level from baseline to 28 days after initial hospitalization | No |
Secondary | Clinical assessment of disease severity with Glasgow score | Disease severity will be assessed with Glasgow score in the first day of hospitalization | 1 day | No |
Secondary | Clinical assessment of disease severity with Glasgow score | Disease severity will be assessed with Glasgow score in the seventh day of hospitalization | 7 day | No |
Secondary | Clinical assessment of disease severity with Glasgow score | Disease severity will be assessed with Glasgow score in the twenty-eighth day of hospitalization | 28 day | No |
Secondary | Clinical assessment of disease severity with pediatric critical illness score | Disease severity will be assessed with pediatric critical illness score in the first day of hospitalization | 1 day | No |
Secondary | Clinical assessment of disease severity with pediatric critical illness score | Disease severity will be assessed with pediatric critical illness score in the seventh day of hospitalization | 7 day | No |
Secondary | Clinical assessment of disease severity with pediatric critical illness score | Disease severity will be assessed with pediatric critical illness score in the twenty-eighth day of hospitalization | 28 day | No |
Secondary | Clinical assessment of disease severity with cerebrospinal fluid examination | Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid | 1 day | No |
Secondary | Clinical assessment of disease severity with cerebrospinal fluid examination | Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid | 7 day | No |
Secondary | Clinical assessment of disease severity with cerebrospinal fluid examination | Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid | 28 day | No |
Secondary | Assessment of complications | Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy. | 1 day | No |
Secondary | Assessment of complications | Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy. | 7 day | No |
Secondary | Assessment of complications | Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy. | 28 day | No |
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