Pneumonia in Children: Aetiology, Ideal Antibiotic Duration, Quality of Life
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Clinical cure
研究概览
简要总结
To determine, in children hospitalized with pneumonia, if an extended duration of oral antibiotics (10 days) will be superior to a shorter duration (3 days) of antibiotics in improving clinical outcomes.
Secondary Aims:
- Describe the prevalence of respiratory viruses and bacteria at presentation.
- Investigate the depression, anxiety and stress scores (DASS21) and quality of life scored (QOL) by parents of the children during admission, pre-discharge and post discharge and at follow-ups.
详细描述
Introduction:
Pneumonia is the single largest cause of death in children less than 5 years old and these are preventable deaths.[1,2] It is also an important cause of morbidity , especially when it is recurrent or severe as it may be linked with future adult lung disease.[3] Determining the aetiology of pneumonia is difficult in children who cannot produce satisfactory sputum for culture. Hence the reliance on molecular methods like polymerase chain reaction (PCR) and Enzyme immunoassays(EIA) looking at serological rise to determine the true aetiology of pneumonia is important especially in the era where mixed infections are common and may be associated with severe infections.
There is currently no information on the suitable duration of antibiotics for uncomplicated severe community acquired pneumonia (CAP). There is also rampant overuse of antibiotics that results in poor compliance and significant side effects.
There is little information on the QOL of the child with severe pneumonia and his parent. It is important to have a holistic approach to medicine hence the importance of analyzing the burden and social issues associated with children admitted with pneumonia.
As opposed to adults, children cannot produce sputum (lower respiratory sample) appropriate for culture which is the traditional method of identifying the causative bacteria. Identification of bacteria in nasopharyngeal secretions (upper respiratory sample) does not equate to that organism causing the infection as the upper airway of a child is often colonized by bacteria. Detecting the organism in blood identifies it as the causative organism. However, blood culture has a very low yield in children with pneumonia and polymerase chain reaction (PCR) is much more sensitive at detecting bacteria in blood and hence it will markedly improve the ability to determine infecting organism.
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)
入排标准
- 年龄范围
- 3 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children admitted with severe pneumonia as defined by the presence of all the following as defined as below:
- •3 months to 59 months old
- •History of cough and/or shortness of breath
- •Unwell for <= 7 days -Increased respiratory rate ( ≥ 50/min if ≤12 months old, ≥ 40/min) or retractions,-
- •Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy
- •Documented fever (axillary /central temp ≥ 38/38.5°C) within 24 hrs of admission
- •Abnormal CXR with presence of alveolar infiltrates
- •Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms
排除标准
- •Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia- (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia
研究组 & 干预措施
Amoxicillin-Potassium Clavulanate
Patient will be on amoxicillin-clavulanate 22.5mg/kg/dose bd for 10 days
干预措施: Amoxicillin-Potassium Clavulanate Combination (Drug)
Placebo
Patient will be on amoxicillin-clavulanate 22.5mg/kg/bd for 3 days followed by another 7 days of placebo medication given at the same dose and frequency
干预措施: Amoxicillin-Potassium Clavulanate Combination (Drug)
Placebo
Patient will be on amoxicillin-clavulanate 22.5mg/kg/bd for 3 days followed by another 7 days of placebo medication given at the same dose and frequency
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical cure
时间窗: 30 days
Complete resolution of symptoms. No treatment failure or exit failure i.e. need for antibiotics or readmission into hospital for a respiratory condition
次要结局
- Quality of life of child and parent(on admission, at discharge, at follow-ups( 4 weeks, 6 months and 1 year))
- Number hospitalised for pneumonia or unscheduled healthcare visits(during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year)
- Bacterial isolates(at the 4 weeks appointment)
- Radiological resolution(at the 4 weeks appointment)
- Prevalence of chronic respiratory symptoms and signs post pneumonia(during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 yea)
- Severity of cough during 4 weeks post-discharge(at the 4 weeks appointment, cough diary which will be done by parents daily from discharge)
- Impact of pneumonia on the parent(on admission, at discharge, at follow-ups(average 1 week, 4 weeks, 6 months and 1 year))
- Severity of pneumonia(during the admission which expected duration will be 5 days, daily twice a day to do the questionnaires)
- Adverse effects(at 4 weeks follow-up)
- Time to next hospitalisation or visit to healthcare unit(during the one year post pneumonic episode; patient will be seen on an avearge of 1 week, 4 weeks, 6 months and 1 year)
研究者
Anna Marie Nathan
Consultant and Associate Professor
University of Malaya