Meningitis in ChildrenNCT03387969
Role of CSF-CRPand Serum Procalcitonin in Differentiation Between Bacterial and Viral Meningitis in Children
An observational study of Meningitis in Children, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Meningitis in Children
- What is being tested?
- CSF sample
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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 .
Read the 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.
.
- Conditions
- Meningitis in Children
- Being tested
- CSF sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF sampleProcedure or surgery
for all patient CSF sample obtained for analysis , culture sensitvity and CSF-CRP.
also blood samples will be collected and analyzed for serum procalcitonin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: CSF sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Meningitis in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud abdelfattah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387969
- Sponsor's protocol ID
- pediatric meningitis
- Status last verified
- Dec 2017
- First submitted
- 24 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17664824Antona 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.
PubMed 17534678Konstantinidis 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.
PubMed 24797775Anh 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.
PubMed 20941894-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
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.
PubMed 9041103Muller 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.
PubMed 11232031Bergallo 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.
PubMed 18026203Big 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.
PubMed 19889944DeBiasi 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.
PubMed 12091076Chen 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.
PubMed 19435724Hofer 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.
PubMed 22507868Christ-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.
PubMed 16208582Mary R, Veinberg F, Couderc R. [Acute meningitidis, acute phase proteins and procalcitonin]. Ann Biol Clin (Paris). 2003 Mar-Apr;61(2):127-37. French.
PubMed 12702467
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of CSF-CRPand Serum Procalcitonin in Differentiation Between Bacterial and Viral Meningitis in Children
- ClinicalTrials.gov ID
- NCT03387969
- Acronym / sponsor ID
- pediatric meningitis
- Conditions
- Meningitis in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| meningitic group | – | Procedure: CSF sampleChildren suffering from fever , disturbed consciousnessand convulsion admitted in emergency department attending to assiut University Children Hospital aged between 2-18 years old |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- Patients at pediatric emergency care unit characterized by:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF samplefor all patient CSF sample obtained for analysis , culture sensitvity and CSF-CRP. also blood samples will be collected and analyzed for serum procalcitonin | Procedure or surgery | meningitic group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Background: PubMed 17664824Tankhiwale 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.
- Background: PubMed 17534678Antona 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.
- Background: PubMed 24797775Konstantinidis 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.
- Background: PubMed 20941894Anh 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.
- Background-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: PubMed 9041103Quagliarello 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.
- Background: PubMed 11232031Muller 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.
- Background: PubMed 18026203Bergallo 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.
- Background: PubMed 19889944Big 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.
- Background: PubMed 12091076DeBiasi 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.
- Background: PubMed 19435724Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis in Children, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amal abdelsalam soliman, MD (01067700334 ext. +2, amalsoliman47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differentiation between bacterial and viral meningitis (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387969, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.