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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT03831906
Eligibility Criteria:
Inclusion criteria:
1. Children aged 2 to 59 months
2. Newly hospitalized for severe pneumonia defined using WHO criteria as cough or difficulty in breathing with:
1. Peripheral oxygen saturation \< 90% or central cyanosis, or
2. Severe respiratory distress (e.g. grunting, nasal flaring, very severe chest indrawing), or
3. Signs of pneumonia, defined as cough or difficulty in breathing with fast breathing (tachypnea) and/or chest indrawing, with any of the following danger signs:
* Inability to breastfeed or drink,
* Persistent vomiting
* Lethargy or reduced level of consciousness
* Convulsions,
* Stridor in calm child
* Severe malnutrition
3. Informed consent signed by parent/guardian
Exclusion criteria:
\- Ongoing TB treatment or history of intake of anti-TB drugs in the last 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
59 Months
Study:
NCT03831906
Study Brief:
Protocol Section:
NCT03831906