E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent respiratory tract infections in children |
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E.1.1.1 | Medical condition in easily understood language |
Recurrent respiratory tract infections in children |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 25.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038133 |
E.1.2 | Term | Recurrent respiratory tract infections |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether antibiotic prophylaxis is more effective than placebo in prevention of respiratory symptoms in children with recurrent respiratory tract infections (RTIs). |
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E.2.2 | Secondary objectives of the trial |
- To identify microbiological, immunological and clinical patient characteristics of prophylaxis failure and benefit. - To determine short-term and long-term effects of co-trimoxazole on other clinical parameters such as morbidity due to other symptoms, quality of life and nutritional status, microbiome deviation, antibiotic resistance and the child’s immune system. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Presenting to one of the participating clinics; - Age 6 months – 5 years; - Suffering from recurrent RTIs.
For age-specific definitions of recurrent RTIs, we took cut-offs as defined by the Dutch Society of Pediatrics, i.e. yearly at least 11 and 8 parental-reported upper RTIs including, but not limited to, otitis media for children aged <2 and 2-5 years respectively. Recurrent lower RTIs (i.e. pneumonia, bronchopneumonia or acute bronchitis) are defined as at least 2 episodes per year or 3 or more episodes during the child’s life regardless of age. |
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study: - Current prophylactic antibiotic use or prophylactic antibiotic use during the previous month; - Underlying immune deficiency other than for IgA or IgG subclasses; - Congenital abnormalities (including cleft palate, neuromuscular, cardial and syndromal disorders, hematologic disorders; - Children who only suffer from recurrent acute otitis media or chronic suppurative otitis media will be excluded since antibiotic prophylaxis has proven to be beneficial for this group; - Known allergy to co-trimoxazole; - Known contra-indication for co-trimoxazole, e.g. liver failure, impaired kidney function and/or hematologic disorders. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of days with respiratory symptoms. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The number of days with respiratory symptoms from baseline to resp. 3 and 6 months after inclusion. |
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E.5.2 | Secondary end point(s) |
Microbiome deviation and antibiotic resistance of nasopharyngeal and gut bacteria. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At inclusion and after 1, 3 and 6 months (+/- 2 weeks for each sample moment). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Evaluating the effect of the prophylactic IMP on the microbiome. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will be ended after the last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |