recurrent respiratory tract infections in children
Conditions
Interventions
Children will be randomized to one of 2 oral regimens for 3 months: co-trimoxazole 36 mg/kg/day (2 x 18 mg/kg) (n=79) or placebo twice daily (n=79).
Sponsors
Juliana Children's Hospital (Haga Teaching Hospital) / UMC Utrecht
Eligibility
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 – 10 years; - Suffering from recurrent respiratory tract infections (RTIs); - Informed consent from parent(s)/caregiver(s) with legal custody. Recurrent upper RTIs: for children aged <2 years yearly at least 11 and for children aged 2-10 years yearly at least 8 parental-reported upper RTIs including, but not limited to, otitis media. 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.
Exclusion criteria
Exclusion criteria: - 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 but not limited to cleft palate, neuromuscular or cardiac disorders and syndromes); - Suffering from chronic respiratory disease, such as cystic fibrosis (CF), primary ciliary dyskinesia (PCD) or anatomical abnormalities; - Only experiencing recurrent AOM or chronic suppurative otitis media without other recurrent RTIs; - Known allergy to co-trimoxazole; - Known contra-indication for co-trimoxazole, e.g. liver failure or impaired kidney function and/or haematologic disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether three months of prophylactic treatment with co-trimoxazole causes a reduction in the number of days a child experiences at least two RTI symptoms in children aged 6 months to =10 years with recurrent RTIs, when compared to placebo. We will use a negative binomial regression analysis with outcome the number of days with at least two respiratory symptoms and use the number of days monitored as offset. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine whether co-trimoxazole prophylactic therapy reduces time to resolution of symptoms, severity of symptoms, use of antipyretics/antibiotics, absenteeism from day-care or school and nutritional status. 2. To examine predictors (e.g. demographic, environmental, family history, mucosal, microbiological and immunological characteristics) for the (absence of) prophylactic treatment effect. 3. To examine whether cessation of antibiotic prophylactic treatment affects the presence of RTI symptoms and how this correlates with clinical, microbiological and immunological characteristics of the patients. 4. To record and evaluate adverse events. 5. To examine short-term and long-term effects of co-trimoxazole prophylaxis on microbiota deviation, AMR and (mucosal and systemic) immunological outcomes. | — |
Contacts
Public ContactD. Peeters
Juliana Children's Hospital
Outcome results
None listed