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

Last updated: July 10, 2019
Sponsor: Grünenthal GmbH
Overall Status: Completed

Phase

3

Condition

Bronchitis

Ear Infections (Pediatric)

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT04016051
KF-DSTCLA/01
  • Ages 2-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bacterialbronchitis requiring antibiotic treatment.

Exclusion

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 (forsafety reasons).

  • Known to or suspected of not being able to comply with the study protocol and the useof clarithromycin.

  • Requirement for, or current use of, systemic antibacterial agents not specified in theprotocol.

  • 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 thenose and throat.

  • History or presence of disease or concomitant medication contraindicating the use ofclarithromycin.

  • 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.

Study Design

Total Participants: 265
Study Start date:
September 22, 2004
Estimated Completion Date:
December 23, 2004

Study 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.

Connect with a study center

  • DE11

    Balve, 58802
    Germany

    Site Not Available

  • DE10

    Beckum, 59269
    Germany

    Site Not Available

  • DE09

    Hameln, 31785
    Germany

    Site Not Available

  • DE08

    Hannover, 30625
    Germany

    Site Not Available

  • DE12

    Künzing, 94550
    Germany

    Site Not Available

  • DE02

    München, 81675
    Germany

    Site Not Available

  • DE03

    München, 81669
    Germany

    Site Not Available

  • DE05

    München, 81241
    Germany

    Site Not Available

  • DE06

    München, 81543
    Germany

    Site Not Available

  • DE13

    München, 81739
    Germany

    Site Not Available

  • DE14

    München, 80393
    Germany

    Site Not Available

  • DE04

    Olching, 82140
    Germany

    Site Not Available

  • DE07

    Pullach im Isartal, 82049
    Germany

    Site Not Available

  • DE01

    Unterhaching, 82008
    Germany

    Site Not Available

  • PL03

    Kozieglowy,
    Poland

    Site Not Available

  • PL06

    Kraków,
    Poland

    Site Not Available

  • PL01

    Lódz,
    Poland

    Site Not Available

  • PL04

    Otwock,
    Poland

    Site Not Available

  • PL05

    Warszawa,
    Poland

    Site Not Available

  • PL02

    Wroclaw,
    Poland

    Site Not Available

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