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

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.

Study Overview

• Status: Completed
• Conditions: Rhinosinusitis; Acute Otitis Media; Acute Bronchitis; Pharyngotonsillitis
• Intervention / Treatment: Other: Antibiotic prescription strategies

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 Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Asociación Colaboración Cochrane Iberoamericana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct antibiotic treatment; The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately.	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.
No Intervention: No antibiotic treatment; The doctor does not give to parents an antibiotic prescription for their son's respiratory infection.
Experimental: Delayed antibiotic prescription; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration and severity of symptoms	Coordination Centre performed telephone interviews.	30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of disease	Included by doctors or coordination centre	30 days

Collaborators and Investigators

• Sponsor: Asociacion Colaboracion Cochrane Iberoamericana
• Collaborators: Instituto de Salud Carlos III; Ministry of Health, Spain
• Investigators: Principal Investigator: Pablo Alonso Coello, PhD, Asociación Colaboración Cochrane Iberoamericana

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): June 7, 2016
• Study Completion (Actual): June 7, 2016

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Satisfaction; Pediatrics; Acute respiratory infections; Delayed antibiotic treatment
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Lung Diseases, Obstructive; Otitis; Otitis Media; Bronchitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: DAP-Pediatrics