ISRCTN76888927已完成3 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
niversity College London (UK)0 个研究点目标入组 824 人开始时间: 2015年12月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 824
研究概览
简要总结
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31123008/ protocol (added 01/06/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34726708/ (added 03/11/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34738518/ (added 08/11/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 31/05/2019:
- •1. Age greater than 6 months and weighing 6 - 24kg
- •2. Clinical diagnosis of CAP at presentation to PED as defined by all of the following:
- •2.1 Presence of cough (reported by parents/guardians within 96 hours prior to presentation) AND
- •2.2 Temperature =38oC measured by any method OR likely fever within 48 hours prior to presentation AND
- •2.3 Signs of laboured/difficult breathing or focal chest signs at presentation in the PED (i.e. one or more of the following):
- •2.3.1 Nasal flaring
- •2.3.2 Chest retractions
- •2.3.3 Abdominal breathing
- •2.3.4 Focal dullness to percussion
- •2.3.5 Focal reduced breath sounds
- •2.3.6 Crackles with asymmetry
- •2.3.7 Lobar pneumonia on chest X-ray (if obtained)
- •3. Prior antibiotic treatment:
- •3.1 Not on systemic antibiotic treatment at presentation OR
- •3.2 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 discussed 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 of the following:
- •2.1 Presence of cough (reported by parents/guardians within 96 hours prior to presentation) AND;
- •2.2 Temperature =38oC measured by any method OR likely fever within 48 hours prior to presentation AND;
- •2.3 Signs of laboured/difficult breathing or focal chest signs (i.e. one or more of the following):
- •2.3.1 Nasal flaring
- •2.3.2 Chest retractions
- •2.3.3 Abdominal breathing
- •2.3.4 Focal dullness to percussion
- •2.3.5 Focal reduced breath sounds
- •2.3.6 Crackles with asymmetry
- •2.3.7 Lobar pneumonia on chest X-ray (if obtained)
- •3. Prior antibiotic treatment including doses administered in hospital (see Figure 2):
- •3.1 Treated in-hospital only with any oral or intravenous beta-lactam for =48 hours after admission
- •3.2 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 a
排除标准
- •Current participant exclusion criteria as of 31/05/2019:
- •1. Severe underlying chronic disease with an increased risk of developing complicated CAP 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 in hospital 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 with an increased risk of complicated CAP 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 antibiotic treatment in total
- •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.
- •Previous participant exclusion criteria from 05/07/2018 to 31/05/2019:
- •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. Need for system 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. Parent/ guardians unlikely to reliably complete the diary because of significant language barriers
- •WARD group:
- •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
研究者
相似试验
进行中（未招募）
1 期
A study looking at how best to treat young children with chest infections.PneumoniaEUCTR2016-000809-36-IEniversity College London800
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-ITPneumoniaEUCTR2016-000809-36-GBMedical Research Council Clinical Trials Unit at UC824
已完成
不适用
The clinical features, antimicrobial susceptibility patterns and genomics of bacteria causing neonatal sepsis in a children’s hospital in Vietnameonatal sepsisNeonatal DiseasesBacterial sepsis of newbornISRCTN69124914Oxford University Clinical Research Unit800
进行中（未招募）
2 期
Assessing how good a single and low dose of primaquine is at stopping the transmission of falciparum malaria between children and mosquitoes and how primaquine is handled by the bodyAcute uncomplicated Plasmodium falciparum malariaInfections and InfestationsPlasmodium falciparum malariaISRCTN16297951niversity of Oxford56
已完成
不适用
The effects of virtual reality exposure therapy (VRET) to treat dental anxietyISRCTN25824611ACTA Amsterdam30