Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT06921993
Eligibility Criteria:
Inclusion Criteria:
* Well-appearing, clinically stable patients aged 3 to 10 years, presenting to the pediatric ED with suspected pneumonia based on a combination of signs and symptoms suggestive of lower respiratory tract infection (LRTI), including:
1. Respiratory Symptoms: Cough, Tachypnea, Dyspnea (Increased work of breathing), Abnormal findings on auscultation.
2. Systemic Symptoms: Fever, Hypoxia, Decreased appetite.
Exclusion Criteria:
* Neonates and children up to 3 years of age, and children older than 10 years
* Children aged 3 to 10 years with any of the following factors:
1. Recent hospitalization (within the past 14 days)
2. Prior CXR or any other chest imaging (e.g. CT scan)
3. Ongoing antibiotic therapy
4. Hemodynamic instability
5. Respiratory failure or severe respiratory distress and/or hypoxemia, requiring urgent assessment for conditions such as pneumothorax, hemothorax, or other emergency respiratory conditions
6. History of aspiration or ab ingestis pneumonia
7. Underlying medical conditions predisposing to severe or recurrent pneumonia, including immunodeficiency, chronic corticosteroid use, chronic lung disease, malignancy, sickle cell disease, congenital heart disease, tracheostomy, and neuromuscular disorders affecting respiration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT06921993
Study Brief:
Protocol Section:
NCT06921993