Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- MeMed BV test result reporting
研究概览
简要总结
Children are commonly hospitalized because of community-acquired pneumonia. Despite the fact that many of these children have viral disease, a majority is treated with antibiotics. These antibiotics will not accelerate recovery in those with viral pneumonia and can cause harm. We are interested in exploring whether the MeMed BV - a composite biomarker assay - could be used to improve antibiotic prescribing in these children by identifying those who likely have viral disease. This proposal describes a feasibility randomized trial of this diagnostic intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 from if they have received >48h of intravenous antibiotics (eg. if transferred from another healthcare facility) or if they have a lobar consolidation that occupies the majority of a lobe on imaging, a pleural effusion that occupies more than ¼ of a lung field, or a positive blood culture for a bacterial pathogen (not a contaminant). Examples of CAP pathogens include S. pneumoniae, S. pyogenes (group A streptococcus), S. aureus, S. anginosus. Examples of contaminants that would be ignored include the coagulase-negative staphylococci and Bacillus spp. 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.
结局指标
主要结局
MeMed BV test result reporting
时间窗: before Day 3
The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling
MeMed BV test result delayed adherence
时间窗: before Day 15
The proportion of participants (who successfully had their antibiotics stopped) that do not have them restarted specifically for CAP treatment prior to discharge
Losses to followup
时间窗: before Day 30
The proportion of participants lost to follow-up
MeMed BV test timing
时间窗: before Day 2
The proportion of participants randomized to the diagnostic intervention who successfully have the MeMed BV performed within 24 h of receipt of the initial dose of IV antibiotics
Consent success
时间窗: Day 0
The proportion of potentially eligible participants who consent
MeMed BV test result initial adherence
时间窗: before Day 4
The proportion of participants found to be high risk for viral infection that successfully have their antibiotics stopped within 24 hours of the test result becoming available
次要结局
- Early clinical response(Day 4)
- Days of antibiotics given specifically for CAP before hospital discharge(Before discharge)
- Time to resolution of hypoxaemia(Before discharge)
- Length of stay in hospital(Before discharge)
- Acceptability of care plan to caregiver(Day 30)
- Time to resolution of difficulty breathing(Before discharge)
- Repeat hospitalization for CAP(After discharge and before day 30)
- Days of antibiotics given specifically for CAP after hospital discharge and before day 30(after hospital discharge and before day 30)
- Time to resolution of fever(Before discharge)
- Unscheduled primary care visits(After discharge and before day 30)
- Unscheduled ED or urgent care visits(After discharge and before day 30)
- Development of complicated pneumonia(Before Day 30)
研究者
Jeffrey
Associate Professor
McMaster University