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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02819856
Eligibility Criteria:
Inclusion Criteria:
* Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation.
* Voluntarily consent to participate in the study.
* Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
* Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or IUD in place for at least 3 months prior to study through study completion; or Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or Stable hormonal contraceptive for at least 3 months prior to study through study completion.
* Ability to perform all behavioral tests as indicated.
Exclusion Criteria:
* Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide).
* History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma.
* History of middle ear or inner ear surgery.
* Current conductive hearing loss or middle ear effusion.
* Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease.
* History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
* Participation in another investigational drug or device study within 30 days prior to study enrollment.
* Female patients who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02819856
Study Brief:
Protocol Section:
NCT02819856