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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT06895135
Eligibility Criteria:
Inclusion Criteria:
* Children aged 1 to 5 years
* Diagnosed with acute otitis media (as per operational definition)
* Both male and female participants
* Parental consent obtained
Exclusion Criteria:
* Children with allergies or contraindications to the trial drugs (amoxicillin or amoxicillin + clavulanic acid)
* Children with asthma or chronic obstructive pulmonary disease (COPD) (as per medical record)
* Children who have received treatment with the trial drugs within the past month
* Children already enrolled in other research programs or who have received trial treatment
* Children with any comorbid conditions that may interfere with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
5 Years
Study:
NCT06895135
Study Brief:
Protocol Section:
NCT06895135