Trial record 10 of 138 for:    Bronchitis: Clinical Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Asociacion Colaboracion Cochrane Iberoamericana
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Ministerio de Sanidad, Servicios Sociales e Igualdad
Information provided by (Responsible Party):
Asociacion Colaboracion Cochrane Iberoamericana
ClinicalTrials.gov Identifier:
NCT01800747
First received: February 26, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    Coordination Centre performed telephone interviews.


Secondary Outcome Measures:
  • Antibiotic consumption [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Self-reported by the patients and checked at the Regional Pharmacy's Units.

  • Parents satisfaction with treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Likert scale.

  • Parents' belief in the efficacy of antibiotics [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Likert scale

  • Impact of DAP strategy on the reconsultation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Medical history review

  • The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Medical history review


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


Estimated Enrollment: 450
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800747

Contacts
Contact: Laura Muñoz Hurtado, MD +34935537814 lmunozh@santpau.cat

Locations
Spain
Asociación Colaboración Cochrane Iberoamericana Recruiting
Barcelona, Spain, 08041
Contact: Pablo Alonso Coello, PhD    +34935537814    palonso@santpau.cat   
Sponsors and Collaborators
Asociacion Colaboracion Cochrane Iberoamericana
Instituto de Salud Carlos III
Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators
Principal Investigator: Pablo Alonso Coello, PhD Asociación Colaboración Cochrane Iberoamericana
  More Information

Additional Information:
No publications provided

Responsible Party: Asociacion Colaboracion Cochrane Iberoamericana
ClinicalTrials.gov Identifier: NCT01800747     History of Changes
Other Study ID Numbers: DAP-Pediatrics
Study First Received: February 26, 2013
Last Updated: February 26, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Bronchitis
Otitis
Otitis Media
Respiratory Tract Infections
Acute Disease
Sinusitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Infection
Disease Attributes
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 29, 2014