Overview
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
Status:
Completed
Completed
Trial end date:
2004-12-23
2004-12-23
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Grünenthal GmbHTreatments:
Clarithromycin
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.