Role of CSF-CRPand Serum Procalcitonin in Differentiation Between Bacterial and Viral Meningitis in Children
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|ClinicalTrials.gov Identifier: NCT03387969|
Recruitment Status : Not yet recruiting
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment|
|Meningitis in Children||Procedure: CSF sample|
Meningitis, since described first in the year 1805, has been one of the major lethal infectious diseases especially for the children in developing countries .Bacterial meningitis, still one of the most life-threatening potentially serious infection worldwide of high morbidity and mortality, it is more prevalent in children and its timely and early differentiation from viral meningitis has a huge impact on the treatment of affected patients with 1.2 million cases per year, resulting in 135 000 deaths.
Case fatality rates for bacterial meningitis range from 4.5% in developed countries to 15-50% in developing countries.
A further 15-20% of survivors sustain neurological sequelae , Including presistant hearing loss and neurologic disability.
The mortality from meningitis is close to 100% in untreated individuals and can still be up to 40% in children who received appropriate antibiotic therapy in developing countries .
Most of these fatalities occur within 72 hours of admission to the hospitals. Neurological outcome and survival depends largely on damage to central nervous system prior to effective antimicrobial therapy. Quick diagnosis and effective management is the key to success . bacterial meningitis commonly caused by N.meningitis , strept.Pneumonia, H.influenza & Group B streptococci. but viral meningitis caused by Enteroviruses 50% , Herpes viruses , respiratory viruses & others itis transmitted by person to person contact through respiratory secretions or droplets.
Diagnostic dilemma is due to large spectrum of signs and symptoms and majority of children who report to hospital have already been treated with inadequate doses of antibiotics and present with atypical features of CSF examination. The only reliable method is bacterial culture of CSF which is positive only in 30-60% and it requires at least 48-72 hrs to be positive. Hence, a test that might help to diagnose and differentiate meningitis earliest is more useful to decrease expensive antibiotic for prolonged duration causing financial burden to poor parents and lengthening of hospital stay .
Hence this study will be conducted to determine and compare the sensitivity, specificity, predictive values and likelihood ratios of such laboratory tests used for diagnosing and differentiating between bacterial and viral meningitis are levels of CRP in CSF and serum procalcitonin with special reference to CSF-CRP level measured by reagent nephelometric method by BN prospec seimense, the major advantage of this method is it's rapid easy two minute reaction time . Serum procalcitonin level for all patient suspected with meningitis measured by chemilumensce on cobas E411 or by ELISA (enzyme linked immunoassay) using blood culture and gram stain as gold standard test.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Role of CSF-CRPand Serum Procalcitonin in Differentiation Between Bacterial and Viral Meningitis in Children|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||July 1, 2020|
Children suffering from fever , disturbed consciousnessand convulsion admitted in emergency department attending to assiut University Children Hospital aged between 2-18 years old
Procedure: CSF sample
for all patient CSF sample obtained for analysis , culture sensitvity and CSF-CRP.
also blood samples will be collected and analyzed for serum procalcitonin
- differentiation between bacterial and viral meningitis [ Time Frame: 12 month ]by using simple bed side diagnostic test as CSF-CRP and procalcitonin confirmed by CSF culture sensitivity and CSF analysis with gram stain
Biospecimen Retention: Samples Without DNA
CSF analysis with culture sensitivity and gram stain .
- CSF-CRP level measured by reagent nephelometric method by BN prospec seimense.
- Serum procalcitonin level for all patient suspected with meningitis measured by chemilumensce on cobas E411 or by ELISA (enzyme linked immunoassay)
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): NCT03387969
|Contact: amal abdelsalam soliman, MD||01067700334 ext +firstname.lastname@example.org|
|Contact: safwat mohammed abd elaziz, MD||01003918080 ext +email@example.com|