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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01800747
First Posted: February 28, 2013
Last Update Posted: July 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Instituto de Salud Carlos III
Ministry of Health, Spain
Information provided by (Responsible Party):
Asociacion Colaboracion Cochrane Iberoamericana
  Purpose
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 Intervention Phase
Rhinosinusitis Acute Bronchitis Acute Otitis Media Pharyngotonsillitis Other: Antibiotic prescription strategies Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Antibiotic 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)

Resource links provided by NLM:


Further study details as provided by Asociacion Colaboracion Cochrane Iberoamericana:

Primary Outcome Measures:
  • Duration and severity of symptoms [ Time Frame: 30 days ]
    Coordination Centre performed telephone interviews.


Secondary Outcome Measures:
  • Antibiotic consumption [ Time Frame: 30 days ]
    Self-reported by the patients and checked at the Regional Pharmacy's Units.

  • Parents satisfaction with treatment [ Time Frame: 30 days ]
    Likert scale.

  • Parents' belief in the efficacy of antibiotics [ Time Frame: 30 days ]
    Likert scale

  • Impact of DAP strategy on the reconsultation [ Time Frame: 1 year ]
    Medical history review

  • The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation. [ Time Frame: 1 year ]
    Medical history review


Other Outcome Measures:
  • Complications of disease [ Time Frame: 30 days ]
    Included by doctors or coordination centre


Enrollment: 450
Actual Study Start Date: June 2012
Study Completion Date: June 7, 2016
Primary Completion Date: June 7, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800747


Locations
Spain
Asociación Colaboración Cochrane Iberoamericana
Barcelona, Spain, 08041
Sponsors and Collaborators
Asociacion Colaboracion Cochrane Iberoamericana
Instituto de Salud Carlos III
Ministry of Health, Spain
Investigators
Principal Investigator: Pablo Alonso Coello, PhD Asociación Colaboración Cochrane Iberoamericana
  More Information

Responsible Party: Asociacion Colaboracion Cochrane Iberoamericana
ClinicalTrials.gov Identifier: NCT01800747     History of Changes
Other Study ID Numbers: DAP-Pediatrics
First Submitted: February 26, 2013
First Posted: February 28, 2013
Last Update Posted: July 31, 2017
Last Verified: July 2017

Keywords provided by Asociacion Colaboracion Cochrane Iberoamericana:
Delayed antibiotic treatment
Acute respiratory infections
Pediatrics
Satisfaction

Additional relevant MeSH terms:
Bronchitis
Respiratory Tract Infections
Otitis Media
Infection
Respiratory Tract Diseases
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents