NCT03387969

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

December 24, 2017

Last Update Submit

December 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    12 month

Study Arms (1)

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

Interventions

CSF samplePROCEDURE

for all patient CSF sample obtained for analysis , culture sensitvity and CSF-CRP. also blood samples will be collected and analyzed for serum procalcitonin

meningitic group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Patients at pediatric emergency care unit characterized by:
  • Age from 2 years to 18 years old.
  • All patients with clinical features suggestive of meningitis presented with fever, convulsions and possible meningeal signs.
  • Immuno-compermised patients or patients on steroids specially.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Tankhiwale SS, Jagtap PM, Khadse RK, Jalgaonkar SV. Bacteriological study of pyogenic meningitis with special reference to C-reactive protein. Indian J Med Microbiol. 2001 Jul-Sep;19(3):159-60.

    PMID: 17664824BACKGROUND
  • Antona D, Leveque N, Chomel JJ, Dubrou S, Levy-Bruhl D, Lina B. Surveillance of enteroviruses in France, 2000-2004. Eur J Clin Microbiol Infect Dis. 2007 Jun;26(6):403-12. doi: 10.1007/s10096-007-0306-4.

    PMID: 17534678BACKGROUND
  • Konstantinidis T, Cassimos D, Gioka T, Tsigalou C, Parasidis T, Alexandropoulou I, Nikolaidis C, Kampouromiti G, Constantinidis T, Chatzimichael A, Panopoulou M. Can Procalcitonin in Cerebrospinal Fluid be a Diagnostic Tool for Meningitis? J Clin Lab Anal. 2015 May;29(3):169-74. doi: 10.1002/jcla.21746. Epub 2014 May 5.

    PMID: 24797775BACKGROUND
  • Anh DD, Riewpaiboon A, Tho le H, Kim SA, Nyambat B, Kilgore P. Treatment costs of pneumonia, meningitis, sepsis, and other diseases among hospitalized children in Viet Nam. J Health Popul Nutr. 2010 Oct;28(5):436-42. doi: 10.3329/jhpn.v28i5.6151.

    PMID: 20941894BACKGROUND
  • -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

    BACKGROUND
  • -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

    BACKGROUND
  • Quagliarello VJ, Scheld WM. Treatment of bacterial meningitis. N Engl J Med. 1997 Mar 6;336(10):708-16. doi: 10.1056/NEJM199703063361007. No abstract available.

    PMID: 9041103BACKGROUND
  • Muller B, White JC, Nylen ES, Snider RH, Becker KL, Habener JF. Ubiquitous expression of the calcitonin-i gene in multiple tissues in response to sepsis. J Clin Endocrinol Metab. 2001 Jan;86(1):396-404. doi: 10.1210/jcem.86.1.7089.

    PMID: 11232031BACKGROUND
  • Bergallo M, Costa C, Margio S, Sidoti F, Terlizzi ME, Cavallo R. Development of a multiplex polymerase chain reaction for detection and typing of major human herpesviruses in cerebrospinal fluid. Can J Microbiol. 2007 Oct;53(10):1117-22. doi: 10.1139/w07-074.

    PMID: 18026203BACKGROUND
  • Big C, Reineck LA, Aronoff DM. Viral infections of the central nervous system: a case-based review. Clin Med Res. 2009 Dec;7(4):142-6. doi: 10.3121/cmr.2009.864. Epub 2009 Nov 4.

    PMID: 19889944BACKGROUND
  • DeBiasi RL, Kleinschmidt-DeMasters BK, Weinberg A, Tyler KL. Use of PCR for the diagnosis of herpesvirus infections of the central nervous system. J Clin Virol. 2002 Jul;25 Suppl 1:S5-11. doi: 10.1016/s1386-6532(02)00028-8.

    PMID: 12091076BACKGROUND
  • Chen DY, Chen YM, Ho WL, Chen HH, Shen GH, Lan JL. Diagnostic value of procalcitonin for differentiation between bacterial infection and non-infectious inflammation in febrile patients with active adult-onset Still's disease. Ann Rheum Dis. 2009 Jun;68(6):1074-5. doi: 10.1136/ard.2008.098335. No abstract available.

    PMID: 19435724BACKGROUND
  • Hofer N, Zacharias E, Muller W, Resch B. An update on the use of C-reactive protein in early-onset neonatal sepsis: current insights and new tasks. Neonatology. 2012;102(1):25-36. doi: 10.1159/000336629. Epub 2012 Apr 11.

    PMID: 22507868BACKGROUND
  • Christ-Crain M, Muller B. Procalcitonin in bacterial infections--hype, hope, more or less? Swiss Med Wkly. 2005 Aug 6;135(31-32):451-60. doi: 10.4414/smw.2005.11169.

    PMID: 16208582BACKGROUND
  • Mary R, Veinberg F, Couderc R. [Acute meningitidis, acute phase proteins and procalcitonin]. Ann Biol Clin (Paris). 2003 Mar-Apr;61(2):127-37. French.

    PMID: 12702467BACKGROUND
  • Tunkel AR, Hartman BJ, Kaplan SL, Kaufman BA, Roos KL, Scheld WM, Whitley RJ. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004 Nov 1;39(9):1267-84. doi: 10.1086/425368. Epub 2004 Oct 6. No abstract available.

    PMID: 15494903BACKGROUND
  • Leveque N, Van Haecke A, Renois F, Boutolleau D, Talmud D, Andreoletti L. Rapid virological diagnosis of central nervous system infections by use of a multiplex reverse transcription-PCR DNA microarray. J Clin Microbiol. 2011 Nov;49(11):3874-9. doi: 10.1128/JCM.01214-11. Epub 2011 Sep 14.

    PMID: 21918017BACKGROUND

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)

Central Study Contacts

amal abdelsalam soliman, MD

CONTACT

safwat mohammed abd elaziz, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 24, 2017

First Posted

January 2, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

July 1, 2020

Last Updated

January 2, 2018

Record last verified: 2017-12