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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
The patients enrolled will be randomized between three treatment strategies or arms. Patients randomized to delayed treatment arm or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.
Asociación Colaboración Cochrane Iberoamericana
Barcelona, Spain
Duration and severity of symptoms
Coordination Centre performed telephone interviews.
Time frame: 30 days
Antibiotic consumption
Self-reported by the patients and checked at the Regional Pharmacy's Units.
Time frame: 30 days
Parents satisfaction with treatment
Likert scale.
Time frame: 30 days
Parents' belief in the efficacy of antibiotics
Likert scale
Time frame: 30 days
Impact of DAP strategy on the reconsultation
Medical history review
Time frame: 1 year
The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.
Medical history review
Time frame: 1 year
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