The Role of Serum Procalcitonin in Diagnosis and Detection of Outcome of Acute Bacterial Meningitis in Childern

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04929925

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Meningitis is one of the most common central nervous system (CNS) infections encountered in infants and children. The source of infection in meningitis can be bacterial, viral, fungal, or parasitic in origin . Bacterial meningitis is a paediatric emergency with high mortality and morbidity rate. Hence it must be diagnosed and treated promptly. But the similar clinical presentation often makes it difficult to differentiate bacterial and non-bacterial aetiologies in children .

Condition or Disease	Intervention/Treatment	Phase
CNS Infection in Children	Diagnostic Test: serum procalcitonin in acute bacterial meningitis

Detailed Description

Currently, cerebrospinal fluid (CSF) analysis has been considered the gold standard for diagnosing bacterial meningitis, along with biomarkers like C-reactive protein (CRP) and white blood cell count (WBC) . However, clinical criteria, gram staining, and bacterial antigen testing of CSF as well as the classic biological markers in blood (CRP, WBC, and neutrophil count) or CSF (protein level, glucose level, WBC, and neutrophil count) used alone do not offer 100% sensitivity and specificity for distinguishing bacterial and non-bacterial meningitis .Moreover, two or more days of waiting is required to identify bacterial growth in CSF cultures Procalcitonin, a 116-amino-acid peptide, which undergoes posttranslational proteolysis into calcitonin, is synthesized in C cells of the thyroid gland and secreted from leukocytes of the peripheral blood. The level of PCT increases (without an increase in calcitonin level) in the presence of bacterial lipopolysaccharides and cytokines that are associated with severe bacterial infections . In contrast to this, there is minimal rise of PCT in patients infected with viruses . Moreover, there is dramatic and quick increase in serum PCT levels after a single endotoxin injection . This type of response to a bacterial stimulus makes PCT level a potentially sensitive marker of severe bacterial infections including meningitis.

After intensive research for new and rapid diagnostic methods for differential diagnosis of meningitis, serum procalcitonin (PCT) has been demonstrated to be the best marker for diagnosis of sepsis that also correlates with the extent and severity of microbial invasion . Procalcitonin is now considered to be clinically most useful and superior to CRP due to its high diagnostic accuracy in various infectious pathologies, including sepsis, acute infectious endocarditis, and pancreatitis .Several studies have demonstrated the raised values of serum PCT in bacterial infections including meningitis . Studies from adults have shown PCT as a powerful diagnostic test for the assessment of suspected meningitis, allowing rapid differentiation between bacterial and non-bacterial (mostly viral) aetiologies, and earlier initiation of appropriate and necessary therapies. The evidence suggests that while serum PCT offers a similar specificity to the traditionally used CSF markers of meningitis, it also confers a higher sensitivity allowing for a more accurate overall diagnosis in patients with suspected meningitis.

There is a little studies on the role of serum procalcitonin in the diagnosis and prognosis of acute bacterial meningitis in children

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Role of Serum Procalcitonin in Diagnosis and Detection of Outcome of Acute Bacterial Meningitis in Children.

Anticipated Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Jul 15, 2022

Anticipated Study Completion Date :

Jul 15, 2022

Outcome Measures

Primary Outcome Measures

To asses the serum level of procalcitonin diagnosis of acute baterial meningitis in children [one year]
to study the role of serum procalcitonin in diagnosis and differentiation of acute bacterial from non-bacterial causes of meningitis. with refrance range : Less than .5ng/ml (no sepsis ) (.5 -2ng/ml ) (follow up is recommended) . more than 2 ng /ml (sepsis )

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All children from one month of age to 14 years old with confirmed and full filling the diagnostic criteria of meningitis .
Cases: children surely diagnosed with acute bacterial meningitis .
Controls: children with suspected non-bacterial meningitis .

Exclusion Criteria:

neonates
children with other systemic or focal infections
children with other neurological problems(CNS hemorrhage or infarction, epilepsy and other causes of convulsions, cerebral palsy and other neurodegenerative and metabolic diseases)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marina Wahib Shawky, resident doctor at pediateric department sohag university hospital, Sohag University

ClinicalTrials.gov Identifier:

NCT04929925

Other Study ID Numbers:

Soh-Med-21-04-01

First Posted:

Jun 18, 2021

Last Update Posted:

Jun 18, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marina Wahib Shawky, resident doctor at pediateric department sohag university hospital, Sohag University

Serum procalcitonim

Additional relevant MeSH terms:

Meningitis, Bacterial

Central Nervous System Infections

Meningitis

Study Results

No Results Posted as of Jun 18, 2021