- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016051
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections (DoSe iT)
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Balve, Germany, 58802
- DE11
-
Beckum, Germany, 59269
- DE10
-
Hameln, Germany, 31785
- DE09
-
Hannover, Germany, 30625
- DE08
-
Künzing, Germany, 94550
- DE12
-
München, Germany, 80393
- DE14
-
München, Germany, 81241
- DE05
-
München, Germany, 81543
- DE06
-
München, Germany, 81669
- DE03
-
München, Germany, 81675
- DE02
-
München, Germany, 81739
- DE13
-
Olching, Germany, 82140
- DE04
-
Pullach im Isartal, Germany, 82049
- DE07
-
Unterhaching, Germany, 82008
- DE01
-
-
-
-
-
Kozieglowy, Poland
- PL03
-
Kraków, Poland
- PL06
-
Lódz, Poland
- PL01
-
Otwock, Poland
- PL04
-
Warszawa, Poland
- PL05
-
Wroclaw, Poland
- PL02
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clarithromycin DST
Participants received oral administration of Clarithromycin DST twice a day:
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. |
Clarithromycin DST (125.0 mg clarithromycin / straw).
Clarithromycin DST (187.5 mg clarithromycin / straw).
Clarithromycin DST (250.0 mg clarithromycin / straw).
|
Active Comparator: Clarithromycin Syrup
Participants received oral administration of Clarithromycin Syrup twice a day:
|
Clarithromycin Syrup 2.5 ml (125 mg).
Other Names:
Clarithromycin Syrup 3.75 ml (187.5 mg).
Other Names:
Clarithromycin Syrup 5 ml (250 mg).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preparation of the medication (during treatment)
Time Frame: Day 3-5
|
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)
Time Frame: Day 11-14
|
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)
Time Frame: Day 3-5
|
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)
Time Frame: Day 11-14
|
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)
Time Frame: Day 3-5
|
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)
Time Frame: Day 11-14
|
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)
Time Frame: Day 3-5
|
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)
Time Frame: Day 11-14
|
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)
Time Frame: Day 3-5
|
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)
Time Frame: Day 11-14
|
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)
Time Frame: Day 3-5
|
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)
Time Frame: Day 11-14
|
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)
Time Frame: Day 3-5
|
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)
Time Frame: Day 11-14
|
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
Time Frame: Day 11-14
|
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
Time Frame: Day 11-14
|
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
Time Frame: Day 11-14
|
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:
The percentage of participants in each of the 3 categories was calculated. |
Day 11-14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child's Health Status compared to Baseline (during treatment)
Time Frame: Day 3-5
|
The participant's overall health status compared to baseline (= acute infection requiring antibiotic treatment) was assessed by the investigator as "cured", "improved", "no changes", or "deteriorated".
The clinical assessment was made during a phone interview with the parent/caregiver on either Day 3, 4, or 5.
The best outcome was "cured", the worst was "deteriorated".
The percentage of participants per outcome category was calculated.
|
Day 3-5
|
Child's Health Status compared to Baseline (after treatment)
Time Frame: Day 11-14
|
The participant's overall health status compared to baseline (= acute infection requiring antibiotic treatment) was assessed by the investigator as "cured", "improved", "no changes", or "deteriorated".
The clinical assessment was made once at a site visit on either Day 11, 12, 13. or 14.
The best outcome was "cured", the worst was "deteriorated".
The percentage of participants per outcome category was calculated.
|
Day 11-14
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Ear Diseases
- Lung Diseases, Obstructive
- Otitis
- Otitis Media
- Bronchitis
- Tonsillitis
- Pharyngitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Clarithromycin
Other Study ID Numbers
- KF-DSTCLA/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Otitis Media
-
David Chi, MDRecruitingRecurrent Acute Otitis Media | Chronic Otitis Media With Effusion | Otitis Media in ChildrenUnited States
-
Bezmialem Vakif UniversityCompleted
-
Alcon ResearchCompletedOtitis Media With Effusion in Children | Otitis Media Recurrent
-
Tusker MedicalCompletedAOM - Acute Otitis Media | OME - Otitis Media With EffusionUnited States, Canada
-
Medical College of WisconsinNational Institutes of Health (NIH); National Institute on Deafness and Other... and other collaboratorsRecruitingOtitis Media | Otitis Media With Effusion | Otitis Media AcuteUnited States
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompletedChronic Serous Otitis Media, Simple or UnspecifiedFrance
-
Nationwide Children's HospitalWithdrawn
-
University Hospital, GhentWithdrawn
-
Yuinvent Innovations Ltd.UnknownOtitis Media With Effusion
-
AcclarentCompletedOtitis Media With EffusionUnited States
Clinical Trials on Clarithromycin DST (125 mg)
-
Neuropore Therapies Inc.CelerionCompletedHealthy VolunteersUnited States
-
Pain TherapeuticsNational Institute on Aging (NIA)CompletedAlzheimer Disease | Alzheimer Disease, Early OnsetUnited States
-
Universitätsklinikum Hamburg-EppendorfRecruiting
-
Pain TherapeuticsNational Institute on Aging (NIA)Completed
-
Napo Pharmaceuticals, Inc.Active, not recruitingAdult Solid Tumor | Cancer Therapy-Related Diarrhea | Chemotherapy-related Diarrhea | Prophylaxis of Diarrhea | Symptomatic Relief of Diarrhea | Targeted Therapy-related DiarrheaUnited States, Taiwan, Georgia, Serbia, Argentina
-
Bausch Health Americas, Inc.CompletedHIV Associated DiarrheaUnited States, Puerto Rico
-
GlaxoSmithKlineCompletedGastroparesisUnited States, Australia, Belgium, United Kingdom, Canada, Sweden
-
GTxCompletedProstate CancerUnited States
-
Cassava Sciences, Inc.National Institute on Aging (NIA)CompletedAlzheimer DiseaseUnited States, Canada