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

Asociacion Colaboracion Cochrane Iberoamericana

Status and phase: Completed; Phase 4

Conditions: Pharyngotonsillitis; Rhinosinusitis; Acute Otitis Media; Acute Bronchitis

Treatments: Other: Antibiotic prescription strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT01800747

DAP-Pediatrics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

450 participants in 3 patient groups

Direct antibiotic treatment

Active Comparator group

Description:

The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately.

Treatment:

Other: Antibiotic prescription strategies

No antibiotic treatment

No Intervention group

Description:

The doctor does not give to parents an antibiotic prescription for their son's respiratory infection.

Delayed antibiotic prescription

Experimental group

Description:

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.

Treatment:

Other: Antibiotic prescription strategies