EUCTR2016-000809-36-GB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
Medical Research Council Clinical Trials Unit at UC0 个研究点目标入组 824 人开始时间: 2016年9月6日最近更新:
适应症
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
- 824
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 from 1 to 5 years (up to their 6th birthday)
- •2. Clinical diagnosis of CAP 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 history of fever in last 24 hours reported by parents/guardians 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
- •3. Decision to treat with oral amoxicillin for CAP on discharge from hospital
- •4. Parent/guardian willing to accept all possible randomised allocations
- •5. 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
- •6. Informed consent form for trial participation signed by parent/guardian.
- •1. Age from 1 to 5 years (up to their 6th birthday)
- •2. Clinical diagnosis of CAP as defined by the all the following :
- •o Presence of cough (reported by parents/guardians in last 96 hours) AND;
- •o Temperature =38oC measured by any method or history of fever in last 24 hours reported by parents/guardians AND;
- •o Signs of laboured/difficult breathing or focal chest signs (i.e. one or more of the following):
- •? Nasal flaring
- •? Chest retractions
- •? Abdominal breathing
- •? Focal dullness to percussion
- •? Focal reduced breath sounds
- •? Crackles with asymmetry
- •3. Admitted to a paediatric assessment unit or inpatient ward at a participating hospital
- •4. Treated with any oral or intravenous beta-lactam for =48 hours after admission
- •5. Decision to further treat with oral amoxicillin for CAP
- •6. Planned for discharge and to continue uninterrupted antibiotic treatment.
- •7. 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.
- •8. Parent/guardian willing to accept all possible randomised allocations
- •9. Informed consent for trial participation signed by a parent/guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2400
- •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. On systemic antibiotic treatment at presentation
- •5. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
- •6. Complicated pneumonia
- •7. Initial decision to treat with oral antibiotic other than amoxicillin on discharge from hospital
- •8. Receipt of initial antibiotic treatment as inpatient in PAU or on the ward*
- •9. Weight >24kg
- •10. 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. Already on systemic antibiotic treatment at presentation
- •5. Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection of non-bacterial aetiology)
- •6. Complicated pneumonia
- •7. Receipt of antibiotic other than a beta-lactam during admission
- •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. Current oxygen requirement
- •10. Current age-specific tachypnoea
- •11. Receipt of >48 hours oral or intravenous inpatient antibiotic treatment
- •12. Decision to treat with oral antibiotic other than amoxicillin on discharge from hospital
- •13. Weight >24kg
- •14. Parents/guardians unlikely to reliably complete the diary because of significant language barriers.
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