Role of CSF-CRPand Serum Procalcitonin in Differentiation Between Bacterial and Viral Meningitis in Children

December 24, 2017 updated by: Mahmoud abdelfattah, Assiut University
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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

December 24, 2017

First Submitted That Met QC Criteria

December 24, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 24, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pediatric meningitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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