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

Phase 3

Recruiting

Conditions: recurrent respiratory tract infections
10019815

Registration Number: NL-OMON54555

Lead Sponsor: HagaZiekenhuis

Brief Summary: Not available

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; -
Age 6 months - 10 years; - Suffering from recurrent respiratory tract
infections (RTIs); - Informed consent from parent(s)/caregiver(s) with legal
custody. For age-specific definitions of recurrent RTIs, we took cut-offs as
defined by the Dutch Society of Pediatric except for children aged 5-10 years
in whom we used the same definition as younger children (2-5 years). This means
yearly at least 11 and 8 parental-reported upper RTIs including, but not
limited to, otitis media for children aged <2 and 2-10 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.

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;
- Suffering from chronic respiratory disease, such as cystic fibrosis (CF),
primary ciliary dyskinesia (PCD) or anatomical abnormalities;
- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine whether antibiotic prophylaxis is more effective than placebo in<br /><br>the prevention of respiratory symptoms in children with recurrent RTIs at a<br /><br>group-level. The difference in days with at least 2 RTI symptoms will be<br /><br>calculated from baseline to 3 months after inclusion. </p><br>

Secondary Outcome Measures