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

Haga Teaching Hospital (Juliana Children's Hospital)0 sites158 target enrollmentMay 7, 2018

Overview

No summary available.

Registry

who.int

Start Date

May 7, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Haga Teaching Hospital (Juliana Children's Hospital)

•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

•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.