Clinical Trial for the Assessment of Delayed Antibiotic Treatment in the Non-complicated Acute Respiratory Tract Infections in Pediatric (Study DAP-Pediatrics)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Duration and severity of symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients not aged between 2 and
- •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.
研究组 & 干预措施
Direct antibiotic treatment
The doctor gives to parents an antibiotic prescription for their son's respiratory infection which he should start immediately.
干预措施: Antibiotic prescription strategies (Other)
No antibiotic treatment
The doctor does not give to parents an antibiotic prescription for their son's respiratory infection.
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.
干预措施: Antibiotic prescription strategies (Other)
结局指标
主要结局
Duration and severity of symptoms
时间窗: 30 days
Coordination Centre performed telephone interviews.
次要结局
- Parents' belief in the efficacy of antibiotics(30 days)
- Impact of DAP strategy on the reconsultation(1 year)
- Antibiotic consumption(30 days)
- Parents satisfaction with treatment(30 days)
- The prescription of antibiotics in the previous two years predicts the effect of prescribing strategies in reconsultation.(1 year)