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

Phase 4

Completed

• Conditions: Acute Otitis Media; Pharyngotonsillitis; Acute Bronchitis; Rhinosinusitis
• Interventions: Other: Antibiotic prescription strategies

• Registration Number: NCT01800747
• Lead Sponsor: Asociacion Colaboracion Cochrane Iberoamericana

Brief 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Primary Completion: 2016-06-07
• Study Completion: 2016-06-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

• Patients not aged between 2 and 14.
• Patients have participated in the DAP-pediatrics previously.
• Patients are severely affected or patients has been felt severely affected for one week (all time).
• Patients with symptoms and signs suggestive of serious illness or severely affected and/or complications (particularly pneumonia, mastoiditis, peritonsillar abscess, peritonsillar cellulitis, intraorbital or intracranial complications).
• Patients at high risk of serious complications due to prior comorbidity. This includes significant heart disease, lung, kidney, liver or neuromuscular, immunosuppression, cystic fibrosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct antibiotic treatment	Antibiotic prescription strategies	The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately.
Delayed antibiotic prescription	Antibiotic prescription strategies	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.

Primary Outcome Measures

Name	Time	Method
Duration and severity of symptoms	30 days	Coordination Centre performed telephone interviews.

Secondary Outcome Measures

Name	Time	Method
Parents' belief in the efficacy of antibiotics	30 days	Likert scale
Impact of DAP strategy on the reconsultation	1 year	Medical history review
Antibiotic consumption	30 days	Self-reported by the patients and checked at the Regional Pharmacy's Units.
Parents satisfaction with treatment	30 days	Likert scale.
The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.	1 year	Medical history review

Trial Locations

Locations (1)

Asociación Colaboración Cochrane Iberoamericana; 🇪🇸 Barcelona, Spain