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

Acute Otitis Media Clinical Trial

— DAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800747
• Other study ID #: DAP-Pediatrics
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2013
• Last updated: July 27, 2017
• Start date: June 2012
• Est. completion date: June 7, 2016

Study information

• Verified date: July 2017
• Source: Asociacion Colaboracion Cochrane Iberoamericana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 7, 2016
• Est. primary completion date: June 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Otitis Media
• Bronchitis
• Otitis Media
• Pharyngotonsillitis
• Respiratory Tract Infections
• Rhinosinusitis

Intervention

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.

Locations

Country	Name	City	State
Spain	Asociación Colaboración Cochrane Iberoamericana	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Asociacion Colaboracion Cochrane Iberoamericana	Instituto de Salud Carlos III, Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications of disease	Included by doctors or coordination centre	30 days
Primary	Duration and severity of symptoms	Coordination Centre performed telephone interviews.	30 days
Secondary	Antibiotic consumption	Self-reported by the patients and checked at the Regional Pharmacy's Units.	30 days
Secondary	Parents satisfaction with treatment	Likert scale.	30 days
Secondary	Parents' belief in the efficacy of antibiotics	Likert scale	30 days
Secondary	Impact of DAP strategy on the reconsultation	Medical history review	1 year
Secondary	The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.	Medical history review	1 year

External Links

•   Click here for more information about our group of research and DAP study.