Clinical trial NCT01800747: Clinical Trial for the Assessment of Delayed Antibiotic Treatment in Pediatric (DAP-Pediatrics)
Official title: Clinical Trial for the Assessment of Delayed Antibiotic Treatment in the Non-complicated Acute Respiratory Tract Infections in Pediatric (Study DAP-Pediatrics)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinosinusitis
Acute Bronchitis
Acute Otitis Media
Pharyngotonsillitis
Keywords: Delayed antibiotic treatment
Acute respiratory infections
Pediatrics
Satisfaction
Lead sponsor: Asociacion Colaboracion Cochrane Iberoamericana
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Ministry of Health, Spain
First posted: 2013-02-28
Enrollment: 450
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Antibiotic treatment versus delayed antibiotic treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration and severity of symptoms
timeFrame: 30 days
Secondary outcomes:
measure: Antibiotic consumption
timeFrame: 30 days
measure: Parents satisfaction with treatment
timeFrame: 30 days
measure: Parents' belief in the efficacy of antibiotics
timeFrame: 30 days
measure: Impact of DAP strategy on the reconsultation
timeFrame: 1 year
measure: The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.
timeFrame: 1 year
Other outcomes:
measure: Complications of disease
timeFrame: 30 days
Locations:
city: Barcelona
country: Spain
facility: Asociación Colaboración Cochrane Iberoamericana
Study officials:
affiliation: Asociación Colaboración Cochrane Iberoamericana
name: Pablo Alonso Coello, PhD
role: PRINCIPAL_INVESTIGATOR
References: