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

HagaZiekenhuis0 个研究点目标入组 158 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•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.

•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.

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