Otitis Media Clinical Trial
Official title:
Comparison of Treatment Satisfaction and Treatment Adherence of a Novel Application Form "Dose Sipping Technology" (DST) of Oral Clarithromycin vs. Clarithromycin Syrup in Children Suffering From Acute Otitis Media, Tonsillitis, Pharyngitis, or Acute Bacterial Bronchitis (DoSe iT)
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.
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