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

Phase 1

• Conditions: Recurrent respiratory tract infections in children; MedDRA version: 25.1Level: LLTClassification code 10038133Term: Recurrent respiratory tract infectionsSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-003164-13-NL
• Lead Sponsor: Haga Teaching Hospital (Juliana Children's Hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-07
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 – 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 158
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>- 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 Outcome Measures

Name	Time	Method
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).