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

• Register: EUCTR
• Last refreshed on: 3 October 2023
• Main ID: EUCTR2017-003164-13-NL
• Date of registration: 07/05/2018
• Prospective Registration: Yes
• Primary sponsor: Haga Teaching Hospital (Juliana Children's Hospital)
• Public title: Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines
• Scientific title: Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines - AppROaCH study
• Date of first enrolment: 17/05/2018
• Target sample size: 158
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003164-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Researchteam
• Affiliation: Juliana Children's Hospital (part of Haga Teaching Hospital)

• Name: Researchteam
• Affiliation: Juliana Children's Hospital (part of Haga Teaching Hospital)

Key inclusion & exclusion 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 <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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Recurrent respiratory tract infections in children
MedDRA version: 25.1 Level: LLT Classification code 10038133 Term: Recurrent respiratory tract infections System Organ Class: 100000004862

Intervention(s)

Trade Name: co-trimoxazole
Product Name: Co-trimoxazole (sulfamethoxazol + trimethoprim)
Pharmaceutical Form: Suspension for oral suspension
Pharmaceutical form of the placebo: Suspension for oral suspension
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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 Outcome(s)

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).

Secondary ID(s)

T17-081

Source(s) of Monetary Support

Haga Teaching Hospital

Ethics review

Status: Approved
Approval date: 17/05/2018
Contact: