Acute Otitis Media Clinical Trial
Official title:
Clinical Trial for the Assessment of Delayed Antibiotic Treatment in the Non-complicated Acute Respiratory Tract Infections in Pediatric (Study DAP-Pediatrics)
The general hypothesis is that delayed antibiotic treatment strategy present similar effectiveness, when compared with non-prescription of antibiotics or the prescription of antibiotics, in the non-complicated acute respiratory tract infections in pediatric patients.
The current project (DAP Pediatrics) is a study that explores the optimization of antibiotic
prescribing in our country by evaluating the delayed prescription of antibiotics. The
proposed trial will take place in the context of a prior similar study we conducted in
adults. The study currently underway is the DAP-Adults study (a randomised controlled trial
that evaluates several antibiotic prescribing strategies, including de delayed prescription
in uncomplicated acute respiratory infections in adults in primary care).
The aim of this study DAP-Pediatrics (randomized, multicenter parallel) to determine the
efficacy and safety of delayed prescription of antibiotics compared to direct prescription
and non-prescription of antibiotic in uncomplicated acute respiratory infections in pediatric
patients. This 3 arms clinical trial will include 450 children and will evaluate the duration
and severity of symptoms, antibiotic consumption, parents' satisfaction, the perceived
efficacy of antibiotics and the number of visits generated. The project also includes a
qualitative study, by means of structured interviews, to assess the perception and attitudes
of parents towards the different treatment strategies and carry out a full analysis of
economic evaluation.
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