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

NCT ID: NCT04016051

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-22
• Study Completion Date: 2004-12-23

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.

Conditions

Otitis Media; Tonsillitis; Pharyngitis; Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clarithromycin DST

Participants received oral administration of Clarithromycin DST twice a day:

• 125.0 mg straw, participants with body weight between 12 and 19 kg (approximate age 2-4 years).
• 187.5 mg straw, participants with body weight between 20 and 29 kg (approximate age 4-8 years).
• 250.0 mg straw, participants with body weight between 30 and 40 kg (approximate age 8-12 years).

For oral intake of DST granules, the lower end of the straw was to be dipped into a glass with a clear, cool or lukewarm, preferably flavored beverage of participant choice. Suitable beverages were lemonade (carbonated or not), clear fruit juices without pulp, tea or water. The beverage was to be sipped smoothly through the straw.

Group Type: EXPERIMENTAL

Clarithromycin DST (125 mg)

Intervention Type: DRUG

Clarithromycin DST (125.0 mg clarithromycin / straw).

Clarithromycin DST (187.5 mg)

Intervention Type: DRUG

Clarithromycin DST (187.5 mg clarithromycin / straw).

Clarithromycin DST (250 mg)

Intervention Type: DRUG

Clarithromycin DST (250.0 mg clarithromycin / straw).

Clarithromycin Syrup

Participants received oral administration of Clarithromycin Syrup twice a day:

• 2.5 ml (125 mg) participants with body weight between 12 and 19 kg (approximate age 2-4 years).
• 3.75 ml (187.5 mg) participants with body weight between 20 and 29 kg (approximate age 4-8 years).
• 5 ml (250 mg) participants with body weight between 30 and 40 kg (approximate age 8-12 years).

Group Type: ACTIVE_COMPARATOR

Clarithromycin Syrup (125 mg)

Intervention Type: DRUG

Clarithromycin Syrup 2.5 ml (125 mg).

Clarithromycin Syrup (187.5 mg)

Intervention Type: DRUG

Clarithromycin Syrup 3.75 ml (187.5 mg).

Clarithromycin Syrup (250 mg)

Intervention Type: DRUG

Clarithromycin Syrup 5 ml (250 mg).

Interventions

Clarithromycin DST (125 mg)

Clarithromycin DST (125.0 mg clarithromycin / straw).

Intervention Type: DRUG

Clarithromycin DST (187.5 mg)

Clarithromycin DST (187.5 mg clarithromycin / straw).

Intervention Type: DRUG

Clarithromycin DST (250 mg)

Clarithromycin DST (250.0 mg clarithromycin / straw).

Intervention Type: DRUG

Clarithromycin Syrup (125 mg)

Clarithromycin Syrup 2.5 ml (125 mg).

Intervention Type: DRUG

Clarithromycin Syrup (187.5 mg)

Clarithromycin Syrup 3.75 ml (187.5 mg).

Intervention Type: DRUG

Clarithromycin Syrup (250 mg)

Clarithromycin Syrup 5 ml (250 mg).

Intervention Type: DRUG

Other Intervention Names

Klacid Syrup® Forte 250 mg/5mL; Klacid Syrup® Forte 250 mg/5mL; Klacid Syrup® Forte 250 mg/5mL

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grünenthal Study Director

Role: STUDY_DIRECTOR

Grünenthal GmbH

Locations

DE11

Balve, , Germany

DE10

Beckum, , Germany

DE09

Hamelin, , Germany

DE08

Hanover, , Germany

DE12

Künzing, , Germany

DE14

München, , Germany

DE05

München, , Germany

DE06

München, , Germany

DE03

München, , Germany

DE02

München, , Germany

DE13

München, , Germany

DE04

Olching, , Germany

DE07

Pullach im Isartal, , Germany

DE01

Unterhaching, , Germany

PL03

Koziegłowy, , Poland

PL06

Krakow, , Poland

PL01

LÓDZ, , Poland

PL04

Otwock, , Poland

PL05

Warsaw, , Poland

PL02

Wroclaw, , Poland

Countries

Germany; Poland

Other Identifiers

KF-DSTCLA/01

Identifier Type: -

Identifier Source: org_study_id