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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT02872558
Eligibility Criteria:
Inclusion:
1. 6 months to 18 years in age
2. Acute Otitis Media diagnosed (AOM) at the time of visit, defined as:
* Middle Ear Effusion- demonstrated by pneumatic otoscopy, air fluid level, or a bulging tympanic membrane PLUS
* Evidence of Acute Inflammation- opaque, white, yellow, or erythematous tympanic membrane or purulent effusion PLUS
* Symptoms of otalgia, fussiness or fever
Exclusion:
1. Are currently on antibiotics
2. Have acute otitis media and another diagnoses that antibiotics are prescribed for
3. Have otitis-conjunctivitis syndrome
4. Have perforation of their tympanic membrane at time of diagnoses
5. Recurrent AOM defined as:
1. ≥3 or greater separate AOM episodes in the previous 6 months or
2. ≥4 or more greater AOM episodes in the previous 12 months with one in the last 6 months
6. Have a craniofacial abnormality
7. Have had previous ear tubes placed
8. Have an immunologic disorder
9. Are immunosuppression either by disease or medication
10. Are undergoing treatment for cancer :
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT02872558
Study Brief:
Protocol Section:
NCT02872558