Clinical trial NCT04016051: Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media
Tonsillitis
Pharyngitis
Bronchitis
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 265
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Preparation of the medication (during treatment)
timeFrame: Day 3-5
measure: Preparation of the medication (after treatment)
timeFrame: Day 11-14
measure: Dosing accuracy (during treatment)
timeFrame: Day 3-5
measure: Dosing accuracy (after treatment)
timeFrame: Day 11-14
measure: Handling of the medication (during treatment)
timeFrame: Day 3-5
measure: Handling of the medication (after treatment)
timeFrame: Day 11-14
measure: Administration of the medication (during treatment)
timeFrame: Day 3-5
measure: Administration of the medication (after treatment)
timeFrame: Day 11-14
measure: Ease to follow the prescribed dosing schedule (during treatment)
timeFrame: Day 3-5
measure: Ease to follow the prescribed dosing schedule (after treatment)
timeFrame: Day 11-14
measure: Child's feeling about the taste of the medication (during treatment)
timeFrame: Day 3-5
measure: Child's feeling about the taste of the medication (after treatment)
timeFrame: Day 11-14
measure: Child's feeling about aftertaste of the medication (during treatment)
timeFrame: Day 3-5
measure: Child's feeling about the aftertaste of the medication (after treatment)
timeFrame: Day 11-14
measure: Optimal administration form
timeFrame: Day 11-14
measure: Treatment preference
timeFrame: Day 11-14
measure: Treatment adherence
timeFrame: Day 11-14
Secondary outcomes:
measure: Child's Health Status compared to Baseline (during treatment)
timeFrame: Day 3-5
measure: Child's Health Status compared to Baseline (after treatment)
timeFrame: Day 11-14
Other outcomes:
Locations:
city: Balve
country: Germany
facility: DE11
city: Beckum
country: Germany
facility: DE10
city: Hameln
country: Germany
facility: DE09
city: Hannover
country: Germany
facility: DE08
city: Künzing
country: Germany
facility: DE12
city: München
country: Germany
facility: DE14
city: München
country: Germany
facility: DE05
city: München
country: Germany
facility: DE06
city: München
country: Germany
facility: DE03
city: München
country: Germany
facility: DE02
city: München
country: Germany
facility: DE13
city: Olching
country: Germany
facility: DE04
city: Pullach im Isartal
country: Germany
facility: DE07
city: Unterhaching
country: Germany
facility: DE01
city: Kozieglowy
country: Poland
facility: PL03
city: Kraków
country: Poland
facility: PL06
city: Lódz
country: Poland
facility: PL01
city: Otwock
country: Poland
facility: PL04
city: Warszawa
country: Poland
facility: PL05
city: Wroclaw
country: Poland
facility: PL02
Study officials:
affiliation: Grünenthal GmbH
name: Grünenthal Study Director
role: STUDY_DIRECTOR
References: