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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT02372461
Eligibility Criteria:
Inclusion Criteria:
* History of cough or difficult breathing \< 14 days (observed or reported) AND
* Respiratory rate ≥ 50 breaths per minute in children 2 to \<12 months (on two consecutive readings by independent physicians) OR respiratory rate ≥ 40 breaths per minute in children12- 59 months (on two consecutive readings by independent physicians) AND
* Written informed consent by a legal guardian
Exclusion Criteria:
* Previously enrolled in study
* Pedal edema
* History of hospitalization in last two weeks
* With severe lower chest wall in-drawing
* Known asthmatics,TB or other severe illness
* Antibiotics taken in last 48 hours
* Bulging fontanel
* Congenital heart disease
* Any surgical condition requiring hospitalization
* Out of catchment area
* Any general danger sign as defined by WHO: Stridor when calm; hypoxia (SaO2 \< 90% in air) ; inability to feed; persistent vomiting (after three attempts to feed the baby within ½ hour); convulsions; reduced conscious level
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
59 Months
Study:
NCT02372461
Study Brief:
Protocol Section:
NCT02372461