1. Study protocol for a randomised controlled trial evaluating the clinical effect of antibiotic prophylaxis in children with recurrent respiratory tract infections
- Author
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Daphne Peeters, Lilly M. Verhagen, Nan van Geloven, Annemarie M. C. van Rossum, Debby Bogaert, Gertjan J A Driessen, Loes E. Visser, RS: GROW - R4 - Reproductive and Perinatal Medicine, Kindergeneeskunde, Epidemiology, Pharmacy, and Pediatrics
- Subjects
0301 basic medicine ,Pediatrics ,medicine.medical_specialty ,BIRTH ,AZITHROMYCIN ,lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4] ,paediatric infectious disease & immunisation ,Azithromycin ,Placebo ,law.invention ,COLONIZATION ,paediatrics ,03 medical and health sciences ,DOUBLE-BLIND ,respiratory infections ,0302 clinical medicine ,All institutes and research themes of the Radboud University Medical Center ,Double-Blind Method ,Randomized controlled trial ,law ,medicine ,Humans ,030212 general & internal medicine ,Antibiotic prophylaxis ,Child ,Adverse effect ,Respiratory Tract Infections ,Randomized Controlled Trials as Topic ,clinical trials ,CYSTIC-FIBROSIS ,Respiratory tract infections ,business.industry ,Drug Resistance, Microbial ,General Medicine ,Antibiotic Prophylaxis ,CARE ,medicine.disease ,Comorbidity ,Anti-Bacterial Agents ,Clinical trial ,COTRIMOXAZOLE ,Treatment Outcome ,030104 developmental biology ,Medicine ,business ,medicine.drug - Abstract
IntroductionRespiratory tract infections (RTIs) affect children all over the world and are associated with significant morbidity and mortality. In particular, recurrent RTIs cause a high burden of disease and lead to frequent doctor visits. Children with recurrent RTIs generally have no significant alterations or deficits in systemic immunity. In an attempt to treat the assumed bacterial component involved, they are often treated with prolonged courses of prophylactic antibiotics taken on a daily basis. Despite its common use, there is no evidence that this is beneficial. Studies assessing the clinical effectiveness of antibiotic prophylaxis as well as potential adverse effects and antibiotic resistance development, are therefore urgently needed.Methods and analysisWe present a protocol for a randomised double-blind placebo-controlled trial comparing co-trimoxazole with placebo treatment in children with recurrent RTIs. A total of 158 children (aged 6 months–10 years) with recurrent RTIs without significant comorbidity will be enrolled from a minimum of 10 Dutch hospitals. One group receives co-trimoxazole 18 mg/kg two times per day (36 mg/kg/day) and the other group receives a placebo two times per day for a period of 3 months. The main objective is to determine whether antibiotic prophylaxis is more effective than placebo to prevent/reduce respiratory symptoms in children with recurrent RTIs. Respiratory symptoms will be scored by parents on a daily basis in both study arms by the use of a mobile phone application. Our primary outcome will be the number of days with at least two respiratory symptoms during the treatment.Ethics and disseminationEthics approval was obtained from the Medical Ethics Research Committee Zuidwest Holland/LDD. A manuscript with the study results will be submitted to a peer-reviewed journal. All participants will be informed about the study results. The results of the study will inform clinical guidelines regarding the prophylactic treatment of children with recurrent RTIs.Trial registration numberNL7044.
- Published
- 2021