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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT00645203
Eligibility Criteria:
Inclusion Criteria:
* Male and female children between 6 months and 4 years of age
* Weight does not exceed 40 kg
* Clinical diagnosis is acute otitis media
* Have evidence of middle ear fluid
* At risk for persistent or recurrent otitis media
* Generally in good health
Exclusion Criteria:
* Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications
* Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
* Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
* Concomitant infection, that requires additional antimicrobial therapy
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
4 Years
Study:
NCT00645203
Study Brief:
Protocol Section:
NCT00645203