NCT01800747

Clinical Trial for the Assessment of Delayed Antibiotic Treatment in Pediatric (DAP-Pediatrics)

Clinical Trial for the Assessment of Delayed Antibiotic Treatment in the Non-complicated Acute Respiratory Tract Infections in Pediatric (Study DAP-Pediatrics)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Asociacion Colaboracion Cochrane Iberoamericana · Academic / Other
• Sex: All
• Age: 2 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rhinosinusitis
• Acute Bronchitis
• Acute Otitis Media
• Pharyngotonsillitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-06-07
• Completion: 2016-06-07
• First posted: 2013-02-28
• Last updated: 2017-07-31

Locations

1 site across 1 country: Spain