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

Sponsor

Asociacion Colaboracion Cochrane Iberoamericana (Other)

Overall Status

Completed

CT.gov ID

NCT01800747

Collaborator

Instituto de Salud Carlos III (Other), Ministry of Health, Spain (Other)

450

Enrollment

Location

Arms

48.2

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinosinusitis Acute Bronchitis Acute Otitis Media Pharyngotonsillitis	Other: Antibiotic prescription strategies	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Antibiotic treatment versus delayed antibiotic treatmentAntibiotic treatment versus delayed antibiotic treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jun 7, 2016

Actual Study Completion Date :

Jun 7, 2016

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Duration and severity of symptoms [30 days]
Coordination Centre performed telephone interviews.

Secondary Outcome Measures

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.
Parents' belief in the efficacy of antibiotics [30 days]
Likert scale
Impact of DAP strategy on the reconsultation [1 year]
Medical history review
The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation. [1 year]
Medical history review

Other Outcome Measures

Complications of disease [30 days]
Included by doctors or coordination centre

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.