Community-Acquired PneumoniaCAP-SeverityNCT07279675
Clinical Predictors of Severity in Pediatric Community-Acquired Pneumonia at Assiut University Children's Hospital
An observational study of Community-Acquired Pneumonia and Pediatric Pneumonia, run by Assiut University.
Trial summary
This study aims to identify the clinical factors that predict the severity of community-acquired pneumonia (CAP) in pediatric patients. Children admitted to Assiut University Children's Hospital with a diagnosis of CAP will be evaluated through clinical examination, vital signs, laboratory investigations, and… Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Community-Acquired Pneumonia, Pediatric Pneumonia, Lower Respiratory Tract Infection
- What is being tested?
- Assessment of Pneumonia Severity
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1 month to 5 years of both sexes diagnosed with community-acquired pneumonia (CAP) presenting to the pediatric emergency department or admitted to pediatric wards at Assiut University Children's Hospital during the study period (October 2025 - October 2026). Children with hospital-acquired pneumonia, known immunodeficiency, chronic respiratory diseases, or congenital lung malformations are excluded.
Who may be able to join
- Children aged 1 month to 5 years.
- Children of both sexes
- Onset of illness in the community, not more than 48 hours after hospital admission.
Who cannot join
- Children below 1 month, as neonatal pneumonia differs in pathology and management from CAP.
- Children with hospital-acquired pneumonia
- Known primary or secondary immunodeficiency
- Children with chronic respiratory diseases (as cystic fibrosis, bronchiectasis) or congenital lung malformations.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to identify the clinical factors that predict the severity of community-acquired pneumonia (CAP) in pediatric patients. Children admitted to Assiut University Children's Hospital with a diagnosis of CAP will be evaluated through clinical examination, vital signs, laboratory investigations, and radiological findings. The study focuses on determining which clinical features are associated with more severe disease, higher need for oxygen therapy, intensive care admission, or complications. Understanding these predictors may help clinicians recognize severe cases earlier and improve patient management and outcomes.
Read the detailed description
Community-acquired pneumonia (CAP) is one of the most common causes of morbidity and hospitalization among children worldwide. Early recognition of severe cases is essential for timely intervention. However, clinical predictors of severity in pediatric CAP vary across populations, and there is a need for locally applicable evidence to guide clinical decision-making.
This observational cross-sectional study will enroll pediatric patients presenting with community-acquired pneumonia to Assiut University Children's Hospital. The diagnosis of CAP will be established based on clinical assessment and radiological confirmation. For each patient, demographic data, presenting symptoms, physical examination findings, vital signs, laboratory investigations, and radiological features will be recorded systematically according to the study protocol.
The primary objective of this study is to identify the clinical and laboratory predictors that are significantly associated with severe pneumonia. Severity will be assessed based on predefined criteria, including oxygen requirement, respiratory distress indicators, complications, and need for intensive care admission. Secondary objectives include describing the distribution of severity levels among the enrolled patients and assessing the relationship between individual risk factors and disease outcomes.
The results of this study are expected to provide clinically relevant predictors that can support early identification of severe CAP in children, improve triage decisions, and optimize treatment strategies within similar healthcare settings.
- Being tested
- Assessment of Pneumonia Severity
- Keywords
- Community-acquired pneumonia, Clinical risk factors, Hypoxemia
- Medical subject headings
- Community-Acquired Pneumonia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Pneumonia SeverityOther
Participants undergo structured evaluation for pneumonia severity, including:
Clinical predictors (respiratory rate, chest indrawing, hypoxemia, feeding difficulty, mental status, comorbidities) Laboratory markers (complete blood count, RDW, CRP, HCO₃-) Radiological assessment (chest X-ray, CT if indicated) Calculation of RISC score
| Study group | Role | What they receive |
|---|---|---|
| Children With Community-Acquired Pneumonia | This cohort includes all children aged 1 month to 5 years diagnosed with community-acquired pneumonia (CAP) who present to the pediatric emergency department or are admitted to the pediatric wards of Assiut University Children Hospital during the study period (October 2025 - October 2026).
All participants will undergo systematic assessment of severity using clinical predictors, laboratory tests, radiological imaging, and the Respiratory Index of Severity in Children (RISC) score. Receives: Other: Assessment of Pneumonia Severity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of Severity Scores with Clinical Outcomes
The primary outcome will be the correlation coefficient (r value) between the Community-Acquired Pneumonia (CAP) severity score and each clinical outcome.
The clinical outcomes will include:
Length of hospital stay (days) Oxygen requirement (L/min) ICU admission (yes/no) Occurrence of complications (yes/no) Mortality (yes/no)
Measured: 14 days from enrollment (typical hospital stay and outpatient follow-up)
Severity of Community-Acquired Pneumonia Assessed by the Respiratory Index of Severity in Children (RISC)
CAP severity will be assessed using the Respiratory Index of Severity in Children (RISC) score.
The RISC score ranges from 0 to 6, with higher scores indicating more severe disease.
Measured: 4 days from enrollment (typical hospital stay and outpatient follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Sayed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279675
- Sponsor's protocol ID
- AUC-PEDE-CAP-2025
- Acronym
- CAP-Severity
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serin O, Akbasli IT, Cetin SB, Koseoglu B, Deveci AF, Ugur MZ, Ozsurekci Y. Predicting Escalation of Care for Childhood Pneumonia Using Machine Learning: Retrospective Analysis and Model Development. JMIRx Med. 2025 Mar 4;6:e57719. doi: 10.2196/57719.
PubMed 40036666Kapoor A, Awasthi S, Kumar Yadav K. Predicting Mortality and Use of RISC Scoring System in Hospitalized Under-Five Children Due to WHO Defined Severe Community Acquired Pneumonia. J Trop Pediatr. 2022 Jun 6;68(4):fmac050. doi: 10.1093/tropej/fmac050.
PubMed 35727140Anteneh ZA, Arega HE, Mihretie KM. Validation of risk prediction for outcomes of severe community-acquired pneumonia among under-five children in Amhara region, Northwest Ethiopia. PLoS One. 2023 Feb 15;18(2):e0281209. doi: 10.1371/journal.pone.0281209. eCollection 2023.
PubMed 36791115O. Shukla, N. Rathwa, and L. Mude, "Assessment of severity of community acquired pneumonia by paediatric infectious diseases society and clinical and radiological profile in 0-5 year age group," 2024, Accessed: Sep. 17, 2025.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Predictors of Severity in Pediatric Community-Acquired Pneumonia at Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07279675
- Acronym / sponsor ID
- CAP-Severity / AUC-PEDE-CAP-2025
- Keywords
- Community-acquired pneumonia, Clinical risk factors, Hypoxemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 Dec 2025 (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.
This study aims to identify the clinical factors that predict the severity of community-acquired pneumonia (CAP) in pediatric patients. Children admitted to Assiut University Children's Hospital with a diagnosis of CAP will be evaluated through clinical examination, vital signs, laboratory investigations, and radiological findings. The study focuses on determining which clinical features are associated with more severe disease, higher need for oxygen therapy, intensive care admission, or complications. Understanding these predictors may help clinicians recognize severe cases earlier and improve patient management and outcomes.
Detailed description
Community-acquired pneumonia (CAP) is one of the most common causes of morbidity and hospitalization among children worldwide. Early recognition of severe cases is essential for timely intervention. However, clinical predictors of severity in pediatric CAP vary across populations, and there is a need for locally applicable evidence to guide clinical decision-making.
This observational cross-sectional study will enroll pediatric patients presenting with community-acquired pneumonia to Assiut University Children's Hospital. The diagnosis of CAP will be established based on clinical assessment and radiological confirmation. For each patient, demographic data, presenting symptoms, physical examination findings, vital signs, laboratory investigations, and radiological features will be recorded systematically according to the study protocol.
The primary objective of this study is to identify the clinical and laboratory predictors that are significantly associated with severe pneumonia. Severity will be assessed based on predefined criteria, including oxygen requirement, respiratory distress indicators, complications, and need for intensive care admission. Secondary objectives include describing the distribution of severity levels among the enrolled patients and assessing the relationship between individual risk factors and disease outcomes.
The results of this study are expected to provide clinically relevant predictors that can support early identification of severe CAP in children, improve triage decisions, and optimize treatment strategies within similar healthcare settings.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Community-Acquired Pneumonia | – | Other: Assessment of Pneumonia SeverityThis cohort includes all children aged 1 month to 5 years diagnosed with community-acquired pneumonia (CAP) who present to the pediatric emergency department or are admitted to the pediatric wards of Assiut University Children Hospital during the study period (October 2025 - October 2026). All participants will undergo systematic assessment of severity using clinical predictors, laboratory tests, radiological imaging, and the Respiratory Index of Severity in Children (RISC) score. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1 month to 5 years of both sexes diagnosed with community-acquired pneumonia (CAP) presenting to the pediatric emergency department or admitted to pediatric wards at Assiut University Children's Hospital during the study period (October 2025 - October 2026). Children with hospital-acquired pneumonia, known immunodeficiency, chronic respiratory diseases, or congenital lung malformations are excluded.
Key inclusion criteria (3 listed)
- Children aged 1 month to 5 years.
- Children of both sexes
- Onset of illness in the community, not more than 48 hours after hospital admission.
Key exclusion criteria (4 listed)
- Children below 1 month, as neonatal pneumonia differs in pathology and management from CAP.
- Children with hospital-acquired pneumonia
- Known primary or secondary immunodeficiency
- Children with chronic respiratory diseases (as cystic fibrosis, bronchiectasis) or congenital lung malformations.
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 |
|---|---|---|
| Assessment of Pneumonia SeverityParticipants undergo structured evaluation for pneumonia severity, including: Clinical predictors (respiratory rate, chest indrawing, hypoxemia, feeding difficulty, mental status, comorbidities) Laboratory markers (complete blood count, RDW, CRP, HCO₃-) Radiological assessment (chest X-ray, CT if indicated) Calculation of RISC score | Other | Children With Community-Acquired Pneumonia |
Primary outcome
Association of Severity Scores with Clinical Outcomes
Time frame: 14 days from enrollment (typical hospital stay and outpatient follow-up)
The primary outcome will be the correlation coefficient (r value) between the Community-Acquired Pneumonia (CAP) severity score and each clinical outcome. The clinical outcomes will include: Length of hospital stay (days) Oxygen requirement (L/min) ICU admission (yes/no) Occurrence of complications (yes/no) Mortality (yes/no)
Severity of Community-Acquired Pneumonia Assessed by the Respiratory Index of Severity in Children (RISC)
Time frame: 4 days from enrollment (typical hospital stay and outpatient follow-up)
CAP severity will be assessed using the Respiratory Index of Severity in Children (RISC) score. The RISC score ranges from 0 to 6, with higher scores indicating more severe disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 40036666Serin O, Akbasli IT, Cetin SB, Koseoglu B, Deveci AF, Ugur MZ, Ozsurekci Y. Predicting Escalation of Care for Childhood Pneumonia Using Machine Learning: Retrospective Analysis and Model Development. JMIRx Med. 2025 Mar 4;6:e57719. doi: 10.2196/57719.
- Background: PubMed 35727140Kapoor A, Awasthi S, Kumar Yadav K. Predicting Mortality and Use of RISC Scoring System in Hospitalized Under-Five Children Due to WHO Defined Severe Community Acquired Pneumonia. J Trop Pediatr. 2022 Jun 6;68(4):fmac050. doi: 10.1093/tropej/fmac050.
- Background: PubMed 36791115Anteneh ZA, Arega HE, Mihretie KM. Validation of risk prediction for outcomes of severe community-acquired pneumonia among under-five children in Amhara region, Northwest Ethiopia. PLoS One. 2023 Feb 15;18(2):e0281209. doi: 10.1371/journal.pone.0281209. eCollection 2023.
- BackgroundO. Shukla, N. Rathwa, and L. Mude, "Assessment of severity of community acquired pneumonia by paediatric infectious diseases society and clinical and radiological profile in 0-5 year age group," 2024, Accessed: Sep. 17, 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Pneumonia and Pediatric Pneumonia, run by Assiut 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 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: opening soon, as of the sponsor's last update on 12 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Mohamed Hassan, resident (01004231328, esraamhassaan7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of Severity Scores with Clinical Outcomes (time frame: 14 days from enrollment (typical hospital stay and outpatient follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07279675, which also lists 4 linked publications.
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 12 Dec 2025.