- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06377163
Bacterial Pathogens Associated With Community-acquired Pneumonia in Children
Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.
This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gamasa, Egypt, 35712
- Amira Hussin Mohammed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- Inclusion criteria:
- Infants and children aged 28 days to ten years (male and female sexes).
- Patients diagnosed with community-acquired pneumonia.
- Pneumonia was diagnosed if the patient fulfilled has fever (temperature ≥38.3° C), Fast breathing (40 breaths per minute if the child is 1 year up to 10 years old), respiratory distress (tachypnea, retractions) and chest indrawing and cyanosis with compatible chest x-ray findings.
Exclusion criteria:
- Neonates
- Children more than 10 years
- Hospital acquired pneumonia
- Chronic lung disease, immunodeficiency and other congenital anomalies
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Complete blood count
Time Frame: At the baseline evaluation
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From each participant, a sample of 4 ml of fresh venous blood was collected from the peripheral vein by the sterile venipuncture technique & drawn into a vacuumed purple top tube containing an anticoagulant.
It was performed using a fully automated hematology analyzer.
This test measures the amounts and sizes of red blood cells, hemoglobin, white blood cells, and platelets.
It will be aggregated to arrive at one report.
Hemoglobin is usually reported in units of grams per liter, or grams per deciliter.
The analyzer counts red blood cells, reporting the result in units of 106 cells per microliter of blood or 1012 cells per liter, and measures their average size, which is called the mean cell volume and expressed in femtoliters or cubic micrometers.
The total white blood cell count is usually reported in cells per microliter of blood, or 109 cells per liter.
The platelet count can be reported in units of cells per microliter of blood, 103 cells per microliter, or 109 cells per liter.
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At the baseline evaluation
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C-reactive protein (CRP)
Time Frame: At the baseline evaluation
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It was measured quantitatively in human serum by Beckman-Coulter AU Analyzers (USA). Sample preparation: 2 ml of blood in a sterile tube was centrifuged, then used immediately for CRP. C-reactive protein (CRP) is an annular (ring-shaped) pentameric protein found in blood plasma whose circulating concentrations rise in response to inflammation. Traditional CRP measurement only detected CRP in the range of 10 to 1,000 mg/L, whereas high-sensitivity CRP (hs-CRP) detects CRP in the range of 0.5 to 10 mg/L. |
At the baseline evaluation
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Blood culture and sensitivity on admission
Time Frame: At the baseline evaluation
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It was done using the BD Bactec 9050 Blood Culture System (USA, Catalog No. 445800) instrument.
A culture was considered positive if any organism was identified.
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At the baseline evaluation
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Gastric lavage culture or sputum culture on admission
Time Frame: At the baseline evaluation
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It was inserted through the nose and down the stomach after nebulization with hypertonic saline at 5% for 10 seconds.
Suction was applied for up to 15 seconds to collect the swallowed sputum in a sterile container.
A culture was considered positive if any organism was identified.
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At the baseline evaluation
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- acquired pneumonia in children
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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