Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines

Recruiting

Conditions: recurrent respiratory tract infections in children
recidiverende luchtweginfecties bij kinderen

Registration Number: NL-OMON22966

Lead Sponsor: Juliana Children's Hospital (Haga Teaching Hospital) / UMC Utrecht

Brief Summary: one

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 158

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;

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>2. To examine predictors (e.g. demographic, environmental, family history, mucosal, microbiological and immunological characteristics) for the (absence of) prophylactic treatment effect. <br>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. <br>4. To record and evaluate adverse events. <br>5. To examine short-term and long-term effects of co-trimoxazole prophylaxis on microbiota deviation, AMR and (mucosal and systemic) immunological outcomes. <br />