EUCTR2016-000809-36-IE进行中（未招募）1 期
Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia (CAP): a randomised controlled trial. - CAP-IT
niversity College London0 个研究点目标入组 800 人开始时间: 2018年7月24日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The inclusion criteria are different for the patients recruited from PED and from the WARD settings therefore these have been displayed here separately.
- •1. Age greater than 6 months and weighing 6 - 24kg
- •2. Clinical diagnosis of CAP at presentation to PED as defined by all the following:
- •? - Presence of cough (reported by parents/guardians in last 96 hours) AND
- •? - Temperature =38oC measured by any method or likely fever in last 48 hours AND
- •? - Signs of laboured/difficult breathing or focal chest signs at presentation in the PED (i.e. one or more of the following):
- •o Nasal flaring
- •o Chest retractions
- •o Abdominal breathing
- •o Focal dullness to percussion
- •o Focal reduced breath sounds
- •o Crackles with asymmetry
- •o Lobar pneumonia on chest X-ray (if obtained)
- •3. Prior antibiotic treatment:
- •o Not on systemic antibiotic treatment at presentation OR
- •o Treated in the community as an outpatient with uninterrupted oral beta-lactam antibiotics for = 48 hours
- •4. Decision to treat with oral amoxicillin for CAP on discharge from hospital
- •5. Parent/guardian willing to accept all possible randomised allocations
- •6. Available for follow-up for the entire study period, parent/guardian willing to be contacted by telephone at day 4, weeks 1, 2 and 3, and attend a face-to-face follow up visit at 4 weeks after randomisation, unless discuss with MRC CTU
- •7. Informed consent form for trial participation signed by parent/guardian.
- •1. Age greater than 6 months and weighing 6 - 24kg
- •2. Clinical diagnosis of CAP at presentation to hospital as defined by all the following:
- •? - Presence of cough (reported by parents/guardians in last 96 hours) AND
- •? - Temperature =38oC measured by any method or likely fever in last 48 hours AND
- •? - Signs of laboured/difficult breathing or focal chest signs at presentation in the PED (i.e. one or more of the following):
- •o Nasal flaring
- •o Chest retractions
- •o Abdominal breathing
- •o Focal dullness to percussion
- •o Focal reduced breath sounds
- •o Crackles with asymmetry
- •o Lobar pneumonia on chest X-ray (if obtained)
- •3. Prior antibiotic treatment including doses administered in hospital:
- •? - Treated in-hospital only with any oral or intravenous beta-lactam for =48 hours after admission
- •? - Treated initially in the community and subsequently in hospital with any oral or intravenous beta-lactam, without interruption, for =48 hours in total
- •4. Decision to further treat with oral amoxicillin for CAP on discharge from hospital
- •5. Child is considered fit for discharge at time of randomisation
- •6. Available for follow-up for the entire study period, parent/guardian willing to be contacted by telephone at weeks 1, 2 and 3 and attend face-to-face follow up visit at 4 weeks after randomisation, unless discussed with MRC CTU
- •7. Parent/guardian willing to accept all possible randomised allocations
- •8. Informed consent for trial participation signed by a parent/guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 800
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The exclusion criteria are different for the patients recruited from PED and from the WARD settings therefore these have been displayed here separately.
- •1. Severe underlying chronic disease including sickle cell anaemia, primary or secondary immunodeficiency, chronic lung disease and cystic fibrosis
- •2. Documented penicillin allergy
- •3. Any other known contra-indication to amoxicillin
- •4. Need for systemic treatment with an antibiotic other than amoxicillin on discharge from hospital
- •5. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
- •6. Complicated pneumonia
- •7. Receipt of initial antibiotic treatment as inpatient in PAU or on the ward
- •8. Parents/guardians unlikely to reliably complete the diary because of significant language barriers.
- •1. Severe underlying chronic disease including sickle cell anaemia, primary or secondary immunodeficiency, chronic lung disease and cystic fibrosis
- •2. Documented penicillin allergy
- •3. Any other known contra-indication to taking amoxicillin
- •4. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
- •5. Complicated pneumonia
- •6. Receipt of antibiotic other than a beta-lactam during admission
- •7. If treated in the community prior to admission, receipt of a non-beta lactam antibiotic in the community at presentation
- •8. Clinically relevant positive blood culture (i.e. positive blood culture and clinical decision to prolong intravenous treatment for more than 48 hours or inappropriate to switch to amoxicillin therapy)
- •9. Receipt of >48 hours oral or intravenous inpatient antibiotic treatment
- •10. Decision to treat with oral antibiotic other than amoxicillin on discharge from hospital
- •11. Parents/guardians unlikely to reliably complete the diary because of significant language barriers.
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