Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections

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.

The study population were children aged 2-12 years (weight 12-40 kg) suffering from upper respiratory tract infections (acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis) and who needed antibiotic treatment. The study compared treatment satisfaction and treatment adherence of oral clarithromycin DST (125 mg, 187.5 mg, or 250 mg twice daily) with the established oral clarithromycin syrup administered via a graduated syringe (Klacid Syrup Forte®, 250 mg/5mL) at the same fixed daily doses.

Fixed doses of 125 mg, 187.5 mg and 250 mg of clarithromycin DST offer the pediatrician the flexibility to treat children of different body weight and age adequately at the recommended daily dose of 15 (12.5-20) mg/kg. All children were treated for 7 to 10 day (14 to 20 doses). Treatment satisfaction by the guardian/caregiver in terms of handling and administration of the clarithromycin DST straw and the comparator clarithromycin syrup, convenience of the administration, acceptance of taste and aftertaste, and treatment satisfaction with respect to future use was evaluated by means of a Parents' Questionnaire once on either Day 3, 4, or 5 and once on either Day 11, 12, 13, or 14. In addition, treatment adherence/willingness of medication intake and the child's health status were assessed. The safety program comprised recording and evaluation of adverse events and countermeasures.

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.