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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rhinosinusitis, Acute Bronchitis, Acute Otitis Media, Pharyngotonsillitis

Intervention / Treatment
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* Other: Antibiotic prescription strategies


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Antibiotic treatment versus delayed antibiotic treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct antibiotic treatment<br>The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately. | Other: Antibiotic prescription strategies<br>* 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.<br>|
| No Intervention: No antibiotic treatment<br>The doctor does not give to parents an antibiotic prescription for their son's respiratory infection. | |
| Experimental: Delayed antibiotic prescription<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed antibiotic treatment, Acute respiratory infections, Pediatrics, Satisfaction