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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT02630992
Eligibility Criteria:
Inclusion Criteria:
* Age range: 6 to 23 months
* Evidence of AOM
* Recent (within 48 hours) onset of signs and symptoms.
* Middle ear effusion evidenced by the presence of at least 2 of the following: decreased or absent mobility of the tympanic membrane (TM), yellow of white discoloration of the TM, and/or opacification of the TM
* Acute inflammation evidenced by one of the following: 1+ bulging of the TM with either intense erythema or otalgia or 2+ or 3+ bulging of the TM
Exclusion Criteria:
* Toxic appearance (capillary refill \>3 seconds, systolic blood pressure \<60 mm Hg)
* Inpatient hospitalization
* Clinical or anatomical characteristics that might obscure response to treatment (e.g., tympanostomy tubes in place, cleft palate, Down syndrome)
* Sensorineural hearing loss (unilateral or bilateral)
* Allergy to amoxicillin or amoxicillin clavulanate
* Recent treatment of AOM within the last 14 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
23 Months
Study:
NCT02630992
Study Brief:
Protocol Section:
NCT02630992