A Phase 4 interventional study of Antibiotic prescription strategies in Rhinosinusitis, Acute Bronchitis and Acute Otitis Media, sponsored by Asociacion Colaboracion Cochrane Iberoamericana. Completed at 1 site in Spain. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2017-07-31.
Sponsored by Asociacion Colaboracion Cochrane Iberoamericana · Phase 4, Interventional, and Treatment
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 450 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Asociacion Colaboracion Cochrane Iberoamericana is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria:
In this study can be enrolled children (2 to 14 ages) with non-complicated acute respiratory tract infections, including pharyngotonsillitis, rhinosinusitis, acute bronchitis and acute media otitis. The doctors include children with these infections if they have reasonable doubts if they should treat with antibiotics.
General Exclusion Criteria:
The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately.
Other: Antibiotic prescription strategies
The doctor does not give to parents an antibiotic prescription for their son's respiratory infection.
The doctor gives to parents an antibiotic prescription for their son's respiratory infection with the advice to use it if needed, in case of worsening of symptoms or not improve.
Other: Antibiotic prescription strategies
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.
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
Complications of disease
Included by doctors or coordination centre
Time frame: 30 days
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Asociacion Colaboracion Cochrane Iberoamericana