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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
Sponsor:
Information provided by (Responsible Party):
Mahmoud abdelfattah, Assiut University

Brief Summary:
Meningitis is one of the major lethal infectious diseases especially for the children in developing countries .It is not always possible and often very difficult to distinguish between bacterial and viral meningitis according to CSF findings, which is not accurate 100% and leads to unnecessary antibiotic usage , So We tried to find a useful 'bedside' decision-making tool, based on laboratory results readily available at the emergency department .

Condition or disease Intervention/treatment
Meningitis in Children Procedure: CSF sample

Detailed Description:

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
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Group/Cohort Intervention/treatment
meningitic group
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





Primary Outcome Measures :
  1. 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)


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children at pediatric emergency care unit attending to Assuit University Children Hospital Aged from 2 years to 18 years old presented with fever, convulsions, disturbed consciousness and possible meningeal sign
Criteria

Inclusion Criteria:

  • Patients at pediatric emergency care unit characterized by:

    1. Age from 2 years to 18 years old.
    2. All patients with clinical features suggestive of meningitis presented with fever, convulsions and possible meningeal signs.
    3. Immuno-compermised patients or patients on steroids specially.

Exclusion Criteria:

  1. Patients above 18 years old .
  2. patient with acute infections at sites other than central nervous system.
  3. patients with severe hepatic dysfunction .
  4. patient with positive family history of metabolic disease .
  5. patients known to had congenital CNS abnormality.

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): NCT03387969


Contacts
Contact: amal abdelsalam soliman, MD 01067700334 ext +2 amalsoliman47@gmail.com
Contact: safwat mohammed abd elaziz, MD 01003918080 ext +2 safwatabdelaziz371@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:
-Amol R. Shinde1, K. S. Ghorpade2, A. M. Siddiqui1. A study of Cerebrospinal Fluid Adenosine deaminase and C-reactive protein in Bacterial, Tubercular and Viral meningitis. Asian Journal of Biomedical and Pharmaceutical Sciences, 2015; 5(44): 15-18
-Patel N, Patel U, Nagpal AC, Jain RK. Evaluating Utility of C reactive protein in Differentiating Bacterial from Non-Bacterial Meningitis in Tertiary Care Hospital, in Central India . International Journal of Medical Research and Review. April-June, 2013/ Vol 1/ Issue 2

Responsible Party: Mahmoud abdelfattah, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03387969     History of Changes
Other Study ID Numbers: pediatric meningitis
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Meningitis
Meningitis, Viral
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs