Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of Short-course Antibiotic Therapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Consent success
研究概览
简要总结
Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants in all arms will receive 5 days of study medications.
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:
- •documented tachypnoea (>60 bpm for age <1 y, >50 bpm for 1-2 y, >40 bpm for 2-4 y, and >30 bpm for >4 y);
- •cough on exam or by history;
- •increased work of breathing on exam; or
- •auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.
排除标准
- •Children will be excluded if: antibiotics have been discontinued; they received >3 days of effective antibiotic treatment (excluding macrolide treatment) prior to hospitalization; there is supplemental oxygen use or fever within the past 24 h; more than 5 days elapsed since admission; the attending clinical team does not wish to use oral amoxicillin for treatment (because of allergy or any other reason); or the child is taking coumadin-based anticoagulants or tetracycline-type antibiotics (because of potential interactions with amoxicillin). Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.
研究组 & 干预措施
Short-course treatment
5 days of placebo (after participants already received 3-5 days of antibiotics)
干预措施: Placebo (Drug)
Standard-duration treatment
5 days of amoxicillin (after participants already received 3-5 days of antibiotics)
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Consent success
时间窗: Day 0
The proportion of potentially eligible participants who consent
Losses to followup
时间窗: before Day 30
The proportion of participants lost to follow-up
Open-label antibiotic use
时间窗: before Day 30
The proportion of participants who receive open-label (non-study) antibiotics
次要结局
- Proportion of participants with late clinical response(Day 15)
- Proportion of participants with repeat hospitalization for CAP(before Day 30)
- Proportion of participants with drug-related AEs (any severity)(before Day 30)
- Proportion of participants with unscheduled ED or urgent care visits(before Day 30)
- Proportion of participants with serious drug AEs(before Day 30)
- Proportion of participants with unscheduled primary care visits(before Day 30)
- Proportion of participants who develop complicated pneumonia(before Day 30)
研究者
Jeffrey
Associate Professor
McMaster University