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

Haga Teaching Hospital (Juliana Children's Hospital)0 个研究点目标入组 158 人开始时间: 2018年5月7日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Haga Teaching Hospital (Juliana Children's Hospital)