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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT06670833
Eligibility Criteria:
Inclusion Criteria:
* Cough OR Difficulty Breathing AND,
* One of the below:
Fast breathing (tachypnoea) \> 50/minute (2-12 months) \> 40/minute (1-\<5 years) \> 25/minute (5-12 years) OR Lower chest wall indrawing
Exclusion Criteria:
* Presenting for repeat visit/follow-up of a treated lower respiratory tract infection (index illness / non-acute) or enrolled in the study within the preceding 28 days.
* Received antibiotic treatment for more than 48 hours at the time of enrolment.
* WHO IMCI danger signs (inability to drink/breastfeed, vomiting everything, convulsions with this illness, lethargy/unconscious).
* Presence of jaundice.
* Hypoxaemia with oxygen saturation (SpO2) \<88%
* Oxygen saturation (SpO2) \<90% (or country-specific / altitude-adjusted thresholds) i) With signs of severe respiratory distress (such as nasal flaring, grunting, etc.) OR ii) In children \< 6 months
* Requiring non-invasive ventilatory support (i.e., high-flow, bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP))
* Underlying disease associated with increased risk of severe pneumonia or pneumonia of unusual aetiology (e.g., WHO acute malnutrition requiring antibiotics as per local guidelines, severe immunodeficiency)
* HIV positive participant that is either i) less than 12 months old; OR ii) requires admission for this illness; OR iii) known to be uncontrolled on treatment (with a documented VL \>1000c/ml in the previous 6 months)
* Caregiver unavailable at the time of enrolment, or unwilling, to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Days
Maximum Age:
12 Years
Study:
NCT06670833
Study Brief:
Protocol Section:
NCT06670833