Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Trac… (NCT04016051) | Clinical Trial Compass
CompletedPhase 3
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
Germany265 participantsStarted 2004-09-22
Plain-language summary
This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic (clarithromycin). The study investigated a new technology which delivers the antibiotic in a straw (dose sipping technology, DST) in comparison to a marketed syrup.
Who can participate
Age range2 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Preparation of the medication (during treatment)
Timeframe: Day 3-5
2
Preparation of the medication (after treatment)
Timeframe: Day 11-14
3
Dosing accuracy (during treatment)
Timeframe: Day 3-5
4
Dosing accuracy (after treatment)
Timeframe: Day 11-14
5
Handling of the medication (during treatment)
Timeframe: Day 3-5
6
Handling of the medication (after treatment)
Timeframe: Day 11-14
7
Administration of the medication (during treatment)
Timeframe: Day 3-5
8
Administration of the medication (after treatment)