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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT04016051
Eligibility Criteria:
Inclusion Criteria:
* Male and female children weighing 12-40 kg.
* Age 2 -12 years.
* Written informed consent (parents).
* Diagnosis of acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis requiring antibiotic treatment.
Exclusion Criteria:
* Participation in another study of investigational products or of devices parallel to, or less than 4 weeks before study entry, or previous participation in this study (for safety reasons).
* Known to or suspected of not being able to comply with the study protocol and the use of clarithromycin.
* Requirement for, or current use of, systemic antibacterial agents not specified in the protocol.
* Necessity of dose reduction due to any concomitant disease.
* Known human immunodeficiency virus (HIV) positive.
* Other inflammatory/infectious diseases of the ear, the upper respiratory tract or the nose and throat.
* History or presence of disease or concomitant medication contraindicating the use of clarithromycin.
* Known or suspected intolerance / hypersensitivity to macrolides.
* Contraindications according to the clarithromycin Summary of Product Characteristics (SmPC).
* Indication for antibiotic treatment for less than 7 days or more than 10 days.
* If known before entry, bacterial isolate resistant to clarithromycin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT04016051
Study Brief:
Protocol Section:
NCT04016051