Recurrent respiratory tract infections in children MedDRA version: 25.1 Level: LLT Classification code 10038133 Term: Recurrent respiratory tract infections System Organ Class: 100000004862
Conditions
Interventions
Trade Name: co-trimoxazole
Product Name: Co-trimoxazole (sulfamethoxazol + trimethoprim)
Pharmaceutical Form: Suspension for oral suspension
Pharmaceutical form of the placebo: Suspension for oral sus
Sponsors
Haga Teaching Hospital (Juliana Children's Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether antibiotic prophylaxis is more effective than placebo in prevention of respiratory symptoms in children with recurrent respiratory tract infections (RTIs). ;Secondary Objective: - 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.;Primary end point(s): The number of days with respiratory symptoms.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Microbiome deviation and antibiotic resistance of nasopharyngeal and gut bacteria. ;Timepoint(s) of evaluation of this end point: At inclusion and after 1, 3 and 6 months (+/- 2 weeks for each sample moment). | — |
Countries
Netherlands
Contacts
Public ContactResearchteam
Juliana Children's Hospital (part of Haga Teaching Hospital)
Outcome results
None listed