Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,543
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.
详细描述
Primary Objective
To evaluate if out-patient (clinic-based) therapy of young infants with possible serious bacterial infection with 7 days of intramuscular procaine penicillin and gentamicin (reference therapy) is equivalent to:
- (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days;
- (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and
Hypothesis
The proportion of babies who fail therapy at (or before 7) days will be 10% in each group. A 5% or less difference in failure rates will be considered equivalent.
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
- None
入排标准
- 年龄范围
- — 至 59 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Infants 0-59 days old who are residents of catchment population of the study hospitals or clinics
- •One or more of the following five signs: severe chest in-drawing, axillary temperature >38.0C or <35.50 C, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment)
- •Family refuses recommended hospitalization or hospitalization otherwise not feasible
- •Informed consent by a legal guardian.
排除标准
- •Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour)
- •Very low birth weight: weight <1500
- •Hospitalization for illness in the last two weeks
- •Previous inclusion in the study
研究组 & 干预措施
procaine penicillin and gentamicin
Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days
干预措施: procaine penicillin and gentamicin (Drug)
procaine penicillin and gentamicin
Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days
干预措施: procaine penicillin, gentamicin, amoxicillin (Drug)
Amoxicillin and gentamicin
Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days
干预措施: amoxicillin and gentamicin (Drug)
Amoxicillin and gentamicin
Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days
干预措施: procaine penicillin, gentamicin, amoxicillin (Drug)
procaine penicillin, gentamicin, and amoxicillin
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.
干预措施: procaine penicillin, gentamicin, amoxicillin (Drug)
结局指标
主要结局
Treatment failure
时间窗: within 7 days of enrolment
次要结局
未报告次要终点
研究者
Anita Kaniz Mehdi Zaidi
Professor and Chair, Department of Paediatrics and Child Health
Aga Khan University