Role of CSF-CRPand Serum Procalcitonin in Differentiation Between Bacterial and Viral Meningitis in Children
1 other identifier
observational
80
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedFirst Posted
Study publicly available on registry
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJanuary 2, 2018
December 1, 2017
1 year
December 24, 2017
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
Interventions
for all patient CSF sample obtained for analysis , culture sensitvity and CSF-CRP. also blood samples will be collected and analyzed for serum procalcitonin
Eligibility Criteria
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: 17664824BACKGROUNDAntona 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: 17534678BACKGROUNDKonstantinidis 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: 24797775BACKGROUNDAnh 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
BACKGROUNDQuagliarello 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: 9041103BACKGROUNDMuller 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: 11232031BACKGROUNDBergallo 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: 18026203BACKGROUNDBig 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: 19889944BACKGROUNDDeBiasi 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: 12091076BACKGROUNDChen 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: 19435724BACKGROUNDHofer 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: 22507868BACKGROUNDChrist-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: 16208582BACKGROUNDMary 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: 12702467BACKGROUNDTunkel 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: 15494903BACKGROUNDLeveque 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
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
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