- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06720441
Predictors of Improvement and Deterioration of Community Acquired Pneumonia in Children
Predictors of improvement and deterioration of community acquired pneumonia in children Community-acquired pneumonia (CAP) is the most prevalent respiratory infectious disease. It is defined as an acute infection of the lung parenchyma that is acquired outside the hospital. Community-acquired pneumonia (CAP) is one of the most common disorders faced in clinical practice . [1,2] Childhood CAP is the leading cause of death in children younger than five years globally[3] .
Acute phase reactants (APR) are inflammatory mediators that show significant alternations in serum levels in response to inflammation, these markers are responsible for some adverse effects such as anorexia, fever, fatigue, and anemia of chronic illness [4] APR can be applied for the assessment of disease severity in CAP in collaboration with clinical evaluation and pneumonia severity scores [5]. The most common APR are (NLR), CRP, and ESR, changes in the level of these indices can be used in the diagnosis and prognosis of inflammatory and infectious diseases [5] NLR is a rapid, simple, and cheap maker of the systemic inflammatory process, it is calculated as the ratio between neutrophil count to lymphocyte count from peripheral blood sample. Numerous researches have assessed the role of NLR in many infectious diseases such as sepsis, bacteremia, and septic shock, in addition, it can predict the severity and outcome of CAP [6] CRP is one of the best indicators of the acute phase response to inflammation. This serum protein is synthesized by hepatocytes and is classified as an acute-phase protein based on its increased serum concentration during inflammation and infection[7] So, the aim of the current study was to assess levels of APR such as total leucocytic count (TLC), platelets, neutrophils, neutrophils-to-lymphocyte ratio (NLR), CRP, D-dimer, Ferritin, and ESR in patients with CAP (as a primary outcome) and to correlate between their measured values and disease severity (as a secondary outcome)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marina Nageh MNTEshak, Resident physician
- Phone Number: +1068215088
- Email: marinanageh918@gmail.com
Study Contact Backup
- Name: Yasser Faruok YFAbderahim, Assistant professor
- Phone Number: +0 111 116 8123
- Email: Yasser.rezk@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Inclusion Criteria All patients above a month and below 18 years old, both sexes, fulfilling diagnosis of CAP
Exclusion Criteria:
- Non-pulmonary infections, liver, renal, and cardiac diseases.and neonates with age less than a month
Description
Inclusion Criteria All patients above a month and below 18 years old, both sexes, fulfilling diagnosis of CAP
Exclusion Criteria:
- Non-pulmonary infections, liver, renal, and cardiac diseases.and neonates with age less than a month
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relation between acute phase reactants and pneumonia
Time Frame: 1 year
|
Assess levels of APR such as total leucocytic count (TLC), platelets, neutrophils, neutrophils-to-lymphocyte ratio (NLR), CRP, D-dimer, Ferritin, and ESR in patients with CAP (as a primary outcome)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictors of improvement and deterioration of community acquired pneumonia in children
Time Frame: 1 year
|
Predictors of improvement and deterioration of community acquired pneumonia in children
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pneumonia prognosis in child
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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Vanderbilt University Medical CenterCompletedCommunity-acquired PneumoniaUnited States
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University Hospital, ToursCompletedCommunity Acquired PneumoniaFrance
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