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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clarithromycin DST | Experimental | 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. |
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| Clarithromycin Syrup | Active Comparator | Participants received oral administration of Clarithromycin Syrup twice a day:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin DST (125 mg) | Drug | Clarithromycin DST (125.0 mg clarithromycin / straw). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Child's Health Status compared to Baseline (during treatment) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grünenthal Study Director | Grünenthal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DE11 | Balve | 58802 | Germany | |||
| DE10 |
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| Clarithromycin DST (187.5 mg) | Drug | Clarithromycin DST (187.5 mg clarithromycin / straw). |
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| Clarithromycin DST (250 mg) | Drug | Clarithromycin DST (250.0 mg clarithromycin / straw). |
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| Clarithromycin Syrup (125 mg) | Drug | Clarithromycin Syrup 2.5 ml (125 mg). |
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| Clarithromycin Syrup (187.5 mg) | Drug | Clarithromycin Syrup 3.75 ml (187.5 mg). |
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| Clarithromycin Syrup (250 mg) | Drug | Clarithromycin Syrup 5 ml (250 mg). |
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| 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:
The percentage of participants in each of the 3 categories was calculated. | Day 11-14 |
| Day 3-5 |
| Child's Health Status compared to Baseline (after treatment) | 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 |
| Beckum |
| 59269 |
| Germany |
| DE09 | Hamelin | 31785 | Germany |
| DE08 | Hanover | 30625 | Germany |
| DE12 | Künzing | 94550 | Germany |
| DE14 | München | 80393 | Germany |
| DE05 | München | 81241 | Germany |
| DE06 | München | 81543 | Germany |
| DE03 | München | 81669 | Germany |
| DE02 | München | 81675 | Germany |
| DE13 | München | 81739 | Germany |
| DE04 | Olching | 82140 | Germany |
| DE07 | Pullach im Isartal | 82049 | Germany |
| DE01 | Unterhaching | 82008 | Germany |
| PL03 | Koziegłowy | Poland |
| PL06 | Krakow | Poland |
| PL01 | LÓDZ | Poland |
| PL04 | Otwock | Poland |
| PL05 | Warsaw | Poland |
| PL02 | Wroclaw | Poland |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D014069 | Tonsillitis |
| D010612 | Pharyngitis |
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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