A Randomized Trial to Investigate Strategies to Reduce Mortality Among HIV-infected and HIV-exposed Children Admitted With Severe Acute Malnutrition in Mulago Hospital, Kampala, Uganda
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- In hospital mortality
研究概览
简要总结
This study to investigate whether empiric use of an antibiotic with greater antimicrobial sensitivity (ceftriaxone) than standard-of-care (ampicillin plus gentamicin) will reduce mortality among HIV-infected/HEU children admitted to Mwanamugimu Nutrition Unit, Mulago Hospital, Kampala, Uganda.
详细描述
Background
HIV-infected and HIV-exposed-uninfected children (HEU) are at increased risk of developing malnutrition. Severely malnourished children have high mortality rates, but mortality is higher in those that are HIV-infected. Preliminary audits at the Mwanamugimu Nutrition Unit, Mulago Hospital, in 2014 showed that 43% of the severely malnourished children that died were HIV-infected/HEU, despite only 30% of admissions being HIV-infected/HEU, with deaths due to infections in 90% of cases.
Objectives
This study aims to investigate whether empiric use of an antibiotic with greater antimicrobial sensitivity (ceftriaxone) than standard-of-care (ampicillin plus gentamicin) will reduce mortality among HIV-infected/HEU children admitted to Mwanamugimu Nutrition Unit. Secondary objectives include: comparing length of hospitalization, weight-for-height, weight-for-age and height-for-age z-scores between ceftriaxone versus standard of care (ampicillin and gentamicin) treatment arms; ascertaining the pattern/antimicrobial sensitivity of pathogens among participants; determining the prevalence and factors associated with HIV-infection among severely malnourished children; and evaluating the pharmacokinetics (PK) of lopinavir/ritonavir (LPV/r) among severely malnourished HIV-infected children.
Methods
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
- 1 Month 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected children aged 1 to 59 months admitted at Mwanamugimu Nutrition Unit with severe acute malnutrition
- •HIV exposed but uninfected children aged 1 to 59 months admitted at Mwanamugimu Nutrition Unit with severe acute malnutrition
- •For prevalence of HIV-infection sub-study, children presenting with severe acute malnutrition on admission at Mwanamugimu Nutrition Unit.
- •For PK sub-study, the child should have been on antiretroviral therapy for at least 2weeks and should have been in hospital for at least 2weeks.
排除标准
- •For PK sub-study; a child with documented poor adherence to antiretroviral therapy.
- •For PK sub-study; a child known to have vomited the drug on the sampling day.
研究组 & 干预措施
Ceftriaxone
Ceftriaxone will be administered intravenously at a dose of 50 - 75mg/kg once daily
干预措施: Ceftriaxone Sodium (Drug)
Ampicillin and Gentamicin
- Ampicillin will be administered intravenously at a dose of 50mg/kg 6hourly
- Gentamicin will be administered intravenously at a dose 5mg/kg once daily
干预措施: Ampicillin (Drug)
Ampicillin and Gentamicin
- Ampicillin will be administered intravenously at a dose of 50mg/kg 6hourly
- Gentamicin will be administered intravenously at a dose 5mg/kg once daily
干预措施: Gentamicin (Drug)
结局指标
主要结局
In hospital mortality
时间窗: 4 weeks
Cumulative incidence
次要结局
- Weight-for-age z-score(90 days)
- Length of hospitalization(90 days)
- Weight-for-height z-score(90 days)
- Height-for-age z-score(90 days)
- Area under the curve (AUC 0- 12h)(12hours)
- Pattern and antimicrobial sensitivity of pathogens(7 days)
- HIV infection(Baseline)
- Maximum concentration (Cmax)(12hours)
- Concentration at 12hours post dose (C12h)(12hours)
研究者
College of Health Sciences
Associate Professor
Makerere University