Promoting Optimal Treatment for Community-acquired Pneumonia in the Emergency Room (PIONEER): a Prospective, Before-after, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Treatment with antibiotics for community-acquired pneumonia
研究概览
简要总结
Pneumonia in children can be caused by different types of germs such as bacteria and viruses. Giving antibiotics to children with bacterial bugs is helpful while giving antibiotics to children with viruses will not help them. Unfortunately, it is difficult for doctors to tell when a child's pneumonia is caused by bacteria or viruses. Most young children are given antibiotics even though it doesn't help them.
Our study wants to test a new way to care for children with pneumonia so that only children who will benefit from antibiotics will receive them. The study will use a combination of the child's symptoms, x-rays results, and lab testing to better determine if a child needs antibiotics. The study team will then review the testing results and follow up with the patient and their family in the following days to ensure that the child is improving. PIONEER will test a novel care pathway for treating non-severe pediatric pneumonia with the goal of decreasing antibiotic prescription while maintaining equal clinical outcomes to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Diagnosed primarily with community-acquired pneumonia as per the ED MD and are well enough to be discharged home.
- •They also must have any one of:
- •tachypnoea;
- •increased work of breathing; or
- •auscultatory findings consistent with pneumonia;
排除标准
- •Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease (requiring treatment or with exercise restrictions), history of repeated aspiration/velopharyngeal incompetence, malignancy (current or past), immunodeficiency (primary, acquired, or iatrogenic), pneumonia previously (clinically) diagnosed within the past month, or lung abscess diagnosed within the past six months. Children who present with ongoing fever after 4 or more days of beta-lactam therapy active against S. pneumoniae (ie. amoxicillin, amoxicillin-clavulanate, cefprozil, cephalexin, cefadroxil), levofloxacin/moxifloxacin, or doxycycline will not be eligible. Children will not be eligible to participate more than once.
研究组 & 干预措施
Standard care
All participants/caregivers will be asked for consent for point-of-care (POC) blood C-reactive protein (CRP), nasopharyngeal swab for virology/Mycoplasma testing, and urine for pneumococcal antigen (UAg) testing, but, since this testing will not affect care, these are optional (ie. refusal will not preclude enrolment). The RA will phone the caregiver at Day 2-5, Day 14-21, and Day 30 post-enrollment, for outcome ascertainment. Caregivers will be asked to fill out a daily diary (either electronically or on paper) to record the participant's symptoms, clinical progress, and possible drug adverse effects. Caregivers will also be instructed on how to take patient temperature. All participants whose symptoms do not progressively improve will be encouraged to return to the ED to be reassessed, as per standard of care.
Novel Care Pathway
Once a child is diagnosed with non-severe CAP (community-acquired pneumonia) in the ED, specific radiographic findings and point-of-care CRP testing will identify those who require antibiotic treatment immediately. The next day, results of multiplex respiratory pathogen and urine pneumococcal antigen (UAg, optional) testing will be integrated into the care plan, along with additional clinical information about the child gathered remotely, to ensure that only children at appreciable risk for bacterial infection receive antibiotics. Our care pathway uses already-available testing (NPS) in new ways, integrates newer diagnostics (point-of-care CRP, UAg), and includes properly-timed clinical follow up to change how children with non-severe CAP are managed.The research team will follow-up with the participant and caregiver the next day, 2-5 days, 7-21 days and day 30 post-enrolment to ensure clinical stability.
干预措施: Novel Care Pathway (Other)
结局指标
主要结局
Treatment with antibiotics for community-acquired pneumonia
时间窗: Day 0-14
The proportion of participants who receive antibiotics specifically targeting community-acquired pneumonia will be assessed at follow-up visits (as per participant caregiver report) and compared between phases of the study (control phase and intervention phase)
次要结局
- Treatment with broad-spectrum antibiotic therapy for community-acquired pneumonia(Day 0-30)
- Occurence of drug-related adverse events(Day 0-30)
- Caregiver satisfaction with the care plan(Day of enrolment, day 2-5, day 14-21 and day 30 follow-up)
- Level of serum procalcitonin that effectively rules out the need for antimicrobials(Day 0-30)
- Hospitalization for CAP(Day 0-30)
- Development of complicated CAP (ie pleural effusion or PICU admission)(Day 0-30)
- Clinical cure(Day 14-21)
- Number of missed days of school/daycare (participant)(Day 14-21)
- Re-presentation to the ED(Day 0-30)
- Failure to achieve clinical cure in those who have CRP<20 mg/L(Day 0-30)
- Treatment with Mycoplasma-active antibiotics for those in whom Mycoplasma is detected(Day 0-14)
- Development of complicated CAP before day 30(day 0-30)
- Number of days of missed work (caregiver)(Day 14-21)
- Unscheduled visits to primary care (eg family MD, nurse practitioner, physician assistant) before day 30 post-enrolment(Day 0-30)
研究者
Jeffrey Pernica
Head, Division of Infectious Disease
Hamilton Health Sciences Corporation