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

NCT04016051 | Completed Phase 3

• 1 other identifier: KF-DSTCLA/01
• Study Type: interventional
• Target: 265
• Locations: 2 countries
• Sites: 20

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.

Conditions

Otitis Media; Tonsillitis; Pharyngitis; Bronchitis

Outcome Measures

Primary Outcomes (17)

• Preparation of the medication (during treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How was the preparation of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.

  Day 3-5

• Preparation of the medication (after treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How was the preparation of the medication?". Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Dosing accuracy (during treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How do you rate giving the right dose?". Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "difficult" and "very difficult". The best outcome was "very simple", the worst "very difficult". The percentage of responses for each of the possible answers was calculated.

  Day 3-5

• Dosing accuracy (after treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How do you rate giving the right dose?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "difficult" and "very difficult". The best outcome was "very simple", the worst "very difficult". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Handling of the medication (during treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How satisfied are you with the handling of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very satisfied", "satisfied", "less satisfied" and "not satisfied". The best outcome was "very satisfied", the worst "not satisfied". The percentage of responses for each of the possible answers was calculated.

  Day 3-5

• Handling of the medication (after treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How satisfied are you with the handling of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very satisfied", "satisfied", "less satisfied" and "not satisfied". The best outcome was "very satisfied", the worst "not satisfied". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Administration of the medication (during treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How do you judge the administration of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.

  Day 3-5

• Administration of the medication (after treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How do you judge the administration of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Ease to follow the prescribed dosing schedule (during treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How easy is it to follow the dosing schedule?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.

  Day 3-5

• Ease to follow the prescribed dosing schedule (after treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "How easy is it to follow the dosing schedule?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Child's feeling about the taste of the medication (during treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the taste of the medication?". Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.

  Day 3-5

• Child's feeling about the taste of the medication (after treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the taste of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Child's feeling about aftertaste of the medication (during treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the aftertaste of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.

  Day 3-5

• Child's feeling about the aftertaste of the medication (after treatment)

  This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the aftertaste of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Optimal administration form

  This was analyzed by a Parents' Questionnaire by means of the question "Do you think the administration form is optimal for your child?". Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "Yes", "No", and "Do not know". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Treatment preference

  Treatment preference was analyzed by a Parents' Questionnaire by means of the question "Would you or your child prefer this administration form next time?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "Yes" and "No". The percentage of responses for each of the possible answers was calculated.

  Day 11-14

• Treatment adherence

  The child's adherence to the prescribed course of therapy was checked by determining the number of unused straws or the residual volume in the medication bottles, respectively, when unused study medication was returned to the site on Day 11, 12, 13, or 14. A participant was considered to be: * Fully treatment adherent: \>90 % of prescribed doses taken within the prescribed course of therapy. * Partially treatment adherent: 70-90% of prescribed doses taken within the prescribed course of therapy. * Non adherent: Omission of 2 or more consecutive doses or \<70% of prescribed doses taken within the prescribed course of therapy. The percentage of participants in each of the 3 categories was calculated.

  Day 11-14

Secondary Outcomes (2)

• Child's Health Status compared to Baseline (during treatment)

  Day 3-5

• Child's Health Status compared to Baseline (after treatment)

  Day 11-14

Study Arms (2)

Clarithromycin DST

EXPERIMENTAL

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.

Drug: Clarithromycin DST (125 mg); Drug: Clarithromycin DST (187.5 mg); Drug: Clarithromycin DST (250 mg)

Clarithromycin Syrup

ACTIVE COMPARATOR

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).

Drug: Clarithromycin Syrup (125 mg); Drug: Clarithromycin Syrup (187.5 mg); Drug: Clarithromycin Syrup (250 mg)

Interventions

Clarithromycin DST (125 mg) DRUG

Clarithromycin DST (125.0 mg clarithromycin / straw).

Clarithromycin DST

Clarithromycin DST (187.5 mg) DRUG

Clarithromycin DST (187.5 mg clarithromycin / straw).

Clarithromycin DST

Clarithromycin DST (250 mg) DRUG

Clarithromycin DST (250.0 mg clarithromycin / straw).

Clarithromycin DST

Clarithromycin Syrup (125 mg) DRUG

Clarithromycin Syrup 2.5 ml (125 mg).

Also known as: Klacid Syrup® Forte 250 mg/5mL

Clarithromycin Syrup

Clarithromycin Syrup (187.5 mg) DRUG

Clarithromycin Syrup 3.75 ml (187.5 mg).

Also known as: Klacid Syrup® Forte 250 mg/5mL

Clarithromycin Syrup

Clarithromycin Syrup (250 mg) DRUG

Clarithromycin Syrup 5 ml (250 mg).

Also known as: Klacid Syrup® Forte 250 mg/5mL

Clarithromycin Syrup

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (20)

DE11

Balve, 58802, Germany

Location

DE10

Beckum, 59269, Germany

Location

DE09

Hamelin, 31785, Germany

Location

DE08

Hanover, 30625, Germany

Location

DE12

Künzing, 94550, Germany

Location

DE14

München, 80393, Germany

Location

DE05

München, 81241, Germany

Location

DE06

München, 81543, Germany

Location

DE03

München, 81669, Germany

Location

DE02

München, 81675, Germany

Location

DE13

München, 81739, Germany

Location

DE04

Olching, 82140, Germany

Location

DE07

Pullach im Isartal, 82049, Germany

Location

DE01

Unterhaching, 82008, Germany

Location

PL03

Koziegłowy, Poland

Location

PL06

Krakow, Poland

Location

PL01

LÓDZ, Poland

Location

PL04

Otwock, Poland

Location

PL05

Warsaw, Poland

Location

PL02

Wroclaw, Poland

Location

MeSH Terms

Conditions

Otitis Media; Tonsillitis; Pharyngitis; Bronchitis

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Grünenthal Study Director

  Grünenthal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: July 11, 2019
• Study Start: September 22, 2004
• Primary Completion: December 23, 2004
• Study Completion: December 23, 2004
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (6); DE (14)