Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,370
- 试验地点
- 1
- 主要终点
- Clinical failure within 10 days of enrolment
研究概览
简要总结
The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired pneumonia in children presenting at a paediatric Emergency Department (ED).
详细描述
A single-center, non-blinded, pragmatic, randomized-controlled, non-inferiority clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All patients three months old to 18 years of age who had symptoms and signs suggestive of non-severe community acquired pneumonia based on respiratory complaints and a pulmonary infiltrate identified by trained paediatricians or emergency physicians will be eligible to the present study. Study participants will be randomly allocated to receive either amoxicillin (90mg/kg per day) in twice or thrice daily regimen. Primary outcome will be treatment failure within 10 days of enrolment as defined by hospitalisation, need for a change in antibiotic (persistence of fever at 72 hours, clinical deterioration, comorbid condition or development of serious adverse reactions) and death. ED revisits within 72 hours, second course of antibiotic and clinical recurrence rates will be evaluated in the follow-up assessments as well as percent of adverse events encountered, number of days missed (work, school or daycare), coverage vaccination rate, protocol adherence and patient and parental satisfaction. The primary analysis will use an intention-to-treat approach. Per-protocol analysis will also be carried to compare the failure rate. Accounting to a maximal 10% drop-off rate, a sample size of 685 participants per arm was calculated to have a power of 90% to identify a difference of ≤ 5% with an alpha value of 0.05.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients 3 months to 18 years of age attending the pediatric ED and diagnosed with a non-severe pneumonia, will be considered for enrolment. More precisely, the following inclusion criteria will be required:
- •Presence of respiratory symptoms (cough and/or dyspnea)
- •Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
- •Presence of fever
- •Positive chest radiography as interpreted by the treating physician
排除标准
- •Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abcess or pneumatocoele)
- •History of anaphylactic or allergic reaction to penicillin or amoxicillin according to the treating physician.
- •History of a serious nonimmunoglobulin E-mediated reactions (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis) attributed to amoxicilin.
- •Caregiver unable to provide consent (language barrier or lack of caregiver presence)
- •Underlying unstable chronic illness (ie. cystic fibrosis, immune suppression, active tuberculosis, bronchiectasis or active pulmonary malignancies)
- •Persistent/chronic pneumonia syndromes (with symptoms for >2 weeks), suspected by the physician to be caused by atypical pathogens, hospital- acquired pneumonia (been hospitalized within 2 weeks prior to enrolment), aspiration pneumonia or recurrent pneumonias.
- •Any history of receiving amoxicillin within the past month
- •Need hospitalisation for any other reasons (ie. persistent vomiting, severe life-threatening infection such as septicaemia or meningitis requiring intravenous antimicrobial agents)
- •Previous participation in study
研究组 & 干预措施
Twice a day regimen
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.
干预措施: Amoxicillin (Drug)
Thrice a day regimen
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Clinical failure within 10 days of enrolment
时间窗: Day 10 (after enrolment)
As a primary outcome, clinical failure will be defined by any of the following occurring within 10 days of enrolment: * Death or hospitalisation * A need for a change in antibiotic according to the treating physician. In our settings, common reasons to change antibiotic are: * Persistence of fever at 72h * Clinical deterioration: • Clinical deterioration will include the development of lower chest-wall indrawing, central cyanosis, stridor while calm, or danger signs as defined by: inability to drink or breastfeed, convulsions, persistent vomiting, lethargy, or unconsciousness at any time during a child's treatment. * Development of a comorbid condition such as a meningitis, bacteriemia, osteomyelitis or septic arthritis * Allergic reaction
次要结局
- Emergency department revisit within 72 hours(72 hours)
- Second course of antibiotic(1 month)
- Adverse events(10 days)
- Number of working days missed by caregivers or school/daycare days missed by patients(1 month)
- Patient's and parents satisfaction with the discharge instructions' provided and the ease of administration(10 days)
- Clinical recurrence(1 month)
研究者
Jocelyn Gravel
Principal investigator
St. Justine's Hospital