Children Chest InfectionNCT06377163
Bacterial Pathogens Associated With Community-acquired Pneumonia in Children
An observational study of Children Chest Infection, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 28 days to 10 years
- Conditions the study is for
- Children Chest Infection
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 31 Aug 2021
- 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 28 days to 10 years
- All sexes
- Child
Study population: A representative sample of 100 participants was taking by simple random sampling technique from children diagnosed to have community acquired pneumonia from Al Mansoura university hospital and Mansura International Hospital.
Who may be able to join
None listed.
Who cannot join
- Neonates
- Children more than 10 years
- Hospital acquired pneumonia
- Chronic lung disease, immunodeficiency and other congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Children Chest Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete blood count
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.
Measured: At the baseline evaluation
C-reactive protein (CRP)
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.
Measured: At the baseline evaluation
Blood culture and sensitivity on admission
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.
Measured: At the baseline evaluation
Gastric lavage culture or sputum culture on admission
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.
Measured: At the baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Jan 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Chest InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377163
- Sponsor's protocol ID
- acquired pneumonia in children
- Status last verified
- Jun 2024
- First submitted
- 10 Apr 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Pathogens Associated With Community-acquired Pneumonia in Children
- ClinicalTrials.gov ID
- NCT06377163
- Acronym / sponsor ID
- acquired pneumonia in children
- Conditions
- Children Chest Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Apr 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 28 days to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- A representative sample of 100 participants was taking by simple random sampling technique from children diagnosed to have community acquired pneumonia from Al Mansoura university hospital and Mansura International Hospital.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Neonates
- Children more than 10 years
- Hospital acquired pneumonia
- Chronic lung disease, immunodeficiency and other congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete blood count
Time frame: At the baseline evaluation
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.
C-reactive protein (CRP)
Time frame: At the baseline evaluation
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.
Blood culture and sensitivity on admission
Time frame: At the baseline evaluation
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.
Gastric lavage culture or sputum culture on admission
Time frame: At the baseline evaluation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Chest Infection, run by Delta University for Science and Technology at 1 site in Egypt.
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 0 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete blood count (time frame: At the baseline evaluation). The study lists 4 primary outcomes in all. 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 11 Jun 2024.