An observational study in Meningitis in Children, sponsored by Assiut University. Status unknown. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by Assiut University · Observational
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 .
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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268 studies on the registry are indexed under Meningitis; 28 are open to participants now.
This study's planned enrollment of 80 is below the median of 535 across 64 observational studies indexed under Meningitis.
Browse Meningitis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
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Patients at pediatric emergency care unit characterized by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
by using simple bed side diagnostic test as CSF-CRP and procalcitonin confirmed by CSF culture sensitivity and CSF analysis with gram stain
Time frame: 12 month
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Jan 2018; primary completion for Jan 2019, 12 months later.
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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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