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:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT03696303
Eligibility Criteria:
CASES:
Inclusion Criteria:
* Age older than 1 month (31 days) and up to 71 months and 28 days.
* Diagnosis of radiologically confirmed pneumonia per WHO criteria in the ED or hospital within 48 hours of hospital admission
* Signed informed consent by parents or legal guardian to participate in the study
Exclusion Criteria:
* Known immunodeficiency
* Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder
* Significant neurological disorder
* Hospitalization within the previous 30 days for pneumonia or respiratory infection
* Use of parenteral antibiotics for current illness (leading to diagnosis of pneumonia)
* Transferred to the study hospital after already being hospitalized at a different location for ≥ 48 hours
CONTROLS:
Inclusion Criteria:
* Age 1 to 71 months and signed informed consent by parents or legal guardian
Exclusion Criteria:
* Known immunodeficiency
* Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder
* Significant neurological disorder
* Fever or suspicion of community-acquired pneumonia or other respiratory infectious disease (symptoms of cough, congestion, tachypnea, indrawing, etc.)
* Hospitalization within the previous 30 days for pneumonia or respiratory infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
31 Days
Maximum Age:
5 Years
Study:
NCT03696303
Study Brief:
Protocol Section:
NCT03696303