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Study protocol for a randomised controlled trial evaluating the clinical effect of antibiotic prophylaxis in children
Daphne Peeters1, Nan van Geloven2, Loes E Visser3,4
1Department of Paediatrics, Haga Hospital, Juliana Childrens Hospital, Den Haag, Zuid-Holland, The Netherlands.
Insights
This study investigates if daily antibiotic prophylaxis prevents respiratory symptoms in children with recurrent infections. Results will guide clinical guidelines on antibiotic use in pediatric respiratory tract infections.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Trials
Background:
- Recurrent respiratory tract infections (RTIs) in children cause significant illness and frequent healthcare visits.
- Children with recurrent RTIs often lack systemic immune deficits, yet receive prolonged prophylactic antibiotics.
- Evidence for the clinical effectiveness and safety of antibiotic prophylaxis for recurrent RTIs is lacking.
Purpose of the Study:
- To evaluate the efficacy of co-trimoxazole prophylaxis compared to placebo in reducing respiratory symptoms in children with recurrent RTIs.
- To provide evidence-based guidance for the prophylactic treatment of pediatric recurrent respiratory tract infections.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 158 children aged 6 months to 10 years with recurrent RTIs.
- Participants received either co-trimoxazole or placebo twice daily for 3 months.
- Parent-reported daily respiratory symptom scores via a mobile application were used to determine the primary outcome.
Main Results:
- The primary outcome is the number of days with at least two respiratory symptoms during the 3-month treatment period.
- Data collection involved daily symptom scoring by parents using a mobile application.
- The study aims to determine if antibiotic prophylaxis is more effective than placebo.
Conclusions:
- The study protocol is approved by the Medical Ethics Research Committee Zuidwest Holland/LDD.
- Results will be disseminated through a peer-reviewed journal publication.
- Findings are expected to inform clinical guidelines on antibiotic prophylaxis for recurrent RTIs in children.
Introduction:
Respiratory 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 Analysis:
We 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 Dissemination:
Ethics 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 Number:
NL7044.
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