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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01071902
Eligibility Criteria:
Inclusion Criteria:
* 6 months to 12 years of age
* Ear tubes in one or both ears
* Ear drainage visible by parent/guardian
* Ear drainage less than 21 days
* Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
* Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
* Ear tube with antimicrobial activity; ear tube longer than 2.5mm
* Non-tube otorrhea
* No otic surgery other than tube placement in the last year
* No menarchial females; no diabetic patients
* No patients with any disease or condition that would negatively affect the conduct of the study
* No patients taking any other systemic antimicrobial therapy during the study
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patients may not be predisposed to neurosensory hearing loss
* Other protocol-defined exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Years
Study:
NCT01071902
Study Brief:
Protocol Section:
NCT01071902