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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT03996967
Eligibility Criteria:
Inclusion criteria Clinical Pneumonia Patients
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Pediatric patients aged between 2 months and 5 years presenting at the screening sites with respiratory symptoms, i.e. cough or difficulty breathing AND
* One of the following: Increased respiratory rate for age OR indrawing OR SaO2 \< 93% OR grunting OR MUAC \< 11.5 if child is greater or equal than 6 months of age OR visible wasting AND
* Referred to clinician review for probable admission
Definition of increased respiratory rate (rr) for age based on the WHO criteria: respiratory rate (rr) \> \> 50 for 2-11 month old; rr \> 40 for 1-5 years old.
Inclusion criteria Healthy Controls
* No symptoms or signs of any disease
* No malaria infection as detected by microscopy or RDT
* No history of clinical pneumonia or hospital admission
Exclusion criteria Clinical Pneumonia Patients
An individual who meets any of the following criteria will be excluded from participation in this study:
* Suspected tuberculosis based on history of cough lasting \> 2 weeks
* Hospital admission in the previous 2 weeks.
* Children that show any evidence of other conditions that could be worsened by blood collection will be further excluded from this study.
Exclusion criteria Healthy Controls
• Having received a vaccine within the prior 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
5 Years
Study:
NCT03996967
Study Brief:
Protocol Section:
NCT03996967