NCT04016051

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Otitis Media
• Tonsillitis
• Pharyngitis
• Bronchitis

Interventions

Type	Name	Description
DRUG	Clarithromycin DST (125 mg)	Clarithromycin DST (125.0 mg clarithromycin / straw).
DRUG	Clarithromycin DST (187.5 mg)	Clarithromycin DST (187.5 mg clarithromycin / straw).
DRUG	Clarithromycin DST (250 mg)	Clarithromycin DST (250.0 mg clarithromycin / straw).
DRUG	Clarithromycin Syrup (125 mg)	Clarithromycin Syrup 2.5 ml (125 mg).
DRUG	Clarithromycin Syrup (187.5 mg)	Clarithromycin Syrup 3.75 ml (187.5 mg).
DRUG	Clarithromycin Syrup (250 mg)	Clarithromycin Syrup 5 ml (250 mg).

Timeline

• Start date: 2004-09-22
• Primary completion: 2004-12-23
• Completion: 2004-12-23
• First posted: 2019-07-11
• Last updated: 2019-07-11

Locations

20 sites across 2 countries: Germany, Poland