Predictors of Improvement and Deterioration of Community Acquired PneumoniaNCT06720441
Predictors of Improvement and Deterioration of Community Acquired Pneumonia in Children
An observational study of Predictors of Improvement and Deterioration of Community Acquired Pneumonia, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Predictors of Improvement and Deterioration of Community Acquired Pneumonia
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2026
- How long will I take part?
- 20 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
None listed.
Who cannot join
- Non-pulmonary infections, liver, renal, and cardiac diseases.and neonates with age less than a month
Trial locations and contacts
No sites are listed yet.
About this study
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)
Read the detailed description
Assessment of community-acquired pneumonia (CAP) severity in association with various pneumonia severity scores. So, the aim of the 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 and to correlate between their values and disease severity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between acute phase reactants and pneumonia
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)
Measured: 1 year
Secondary outcomes (1)
Predictors of improvement and deterioration of community acquired pneumonia in children
Predictors of improvement and deterioration of community acquired pneumonia in children
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictors of Improvement and Deterioration of 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Nageh Thabet Eshak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720441
- Sponsor's protocol ID
- Pneumonia prognosis in child
- Status last verified
- Sep 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Improvement and Deterioration of Community Acquired Pneumonia in Children
- ClinicalTrials.gov ID
- NCT06720441
- Acronym / sponsor ID
- Pneumonia prognosis in child
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 6 Dec 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.
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)
Detailed description
Assessment of community-acquired pneumonia (CAP) severity in association with various pneumonia severity scores. So, the aim of the 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 and to correlate between their values and disease severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Months
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Non-pulmonary infections, liver, renal, and cardiac diseases.and neonates with age less than a month
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
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 secondary outcome
Predictors of improvement and deterioration of community acquired pneumonia in children
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- 1.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Predictors of Improvement and Deterioration of Community Acquired 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 0 inclusion and 1 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 6 Dec 2024. 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?
Contact Marina Nageh MNTEshak, Resident physician (+1068215088, marinanageh918@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between acute phase reactants and pneumonia (time frame: 1 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 6 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.