CNS Infection in ChildrenNCT04929925
The Role of Serum Procalcitonin in Diagnosis and Detection of Outcome of Acute Bacterial Meningitis in Childern
An observational study of CNS Infection in Children, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- CNS Infection in Children
- What is being tested?
- serum procalcitonin in acute bacterial meningitis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2021to 15 Jul 2022
- How long will I take part?
- 12 Months
- 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 1 month to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with CNS infection from one month to 14 years
Who may be able to join
- 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 .
Who cannot join
- 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)
About this study
Official title: The Role of Serum Procalcitonin in Diagnosis and Detection of Outcome of Acute Bacterial Meningitis in Children.
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 .
Read the detailed description
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 .
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
- Conditions
- CNS Infection in Children
- Being tested
- serum procalcitonin in acute bacterial meningitis
- Keywords
- Serum procalcitonim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum procalcitonin in acute bacterial meningitisDiagnostic test
Serum Procalcitonin estimation will be done by Cobas e411Roch diagnostic,Switzerland apparatus by immunoassay method (electrochemiluminescence immunoassay) by using sample serum or plasma heparin or EDTA with reference range less than 0.5ng/ml ( no sepsis) but 0.5-2ng/ml)follow up is recommended) and more than 2 (sepsis)
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the serum level of procalcitonin diagnosis of acute baterial meningitis in children
- 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 )
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS Infection in ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Wahib Shawky, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929925
- Sponsor's protocol ID
- Soh-Med-21-04-01
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Serum Procalcitonin in Diagnosis and Detection of Outcome of Acute Bacterial Meningitis in Children.
- ClinicalTrials.gov ID
- NCT04929925
- Acronym / sponsor ID
- Soh-Med-21-04-01
- Conditions
- CNS Infection in Children
- Keywords
- Serum procalcitonim
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 18 Jun 2021 (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 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 .
Detailed description
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 .
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with CNS infection from one month to 14 years
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| serum procalcitonin in acute bacterial meningitisSerum Procalcitonin estimation will be done by Cobas e411Roch diagnostic,Switzerland apparatus by immunoassay method (electrochemiluminescence immunoassay) by using sample serum or plasma heparin or EDTA with reference range less than 0.5ng/ml ( no sepsis) but 0.5-2ng/ml)follow up is recommended) and more than 2 (sepsis) | Diagnostic test | – |
Primary outcome
To asses the serum level of procalcitonin diagnosis of acute baterial meningitis in children
Time frame: 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 )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided. 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Infection in Children, run by Sohag 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 3 inclusion and 3 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 18 Jun 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses the serum level of procalcitonin diagnosis of acute baterial meningitis in children (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2021.