Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis, Especially of Pneumococcal Meningitis, in Angola.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Day 7 Mortality
研究概览
简要总结
The main purpose of this trial is to test if mortality of childhood bacterial meningitis can be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional bolus administration four times daily (qid), combined with high-dose paracetamol orally, when both treatments are executed for the first 4 days. The series will be collected at Hospital Pediátrico David Bernardino, Luanda, Angola.
The recruitment of patients begins, the conditions permitting, in early 2012. The criteria for patient participation is a child at the age of 2 months to 15 years who presents with the symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.
详细描述
The principal objective of the study is to examine if mortality of childhood bacterial meningitis can be reduced by slow continuous infusion of cefotaxime combined with high-dose paracetamol orally for the first 4 days (instead of the traditional qid administration of cefotaxime without concomitant paracetamol). Children qualifying for entry (see criteria below), whose guardian has given informed consent,will be randomized into 2 treatment arms (see details below)and receive the treatments in a double blind fashion (see details below). Primary and secondary outcomes (detailed below) will be evaluated according to predefined criteria and time points (see below).
Results will be analyzed for all patients in ITT datasets and in prespecified subgroups (etiology, nutritional status, etc.) in both crude and adjusted analysis. The efficacy results will be expressed as OR with 95% confidence intervals.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Infusion with paracetamol
Cefotaxime is administered as 12 hourly infusions, together with high dose paracetamol (acetaminophen)
干预措施: Infusion with paracetamol (Drug)
Bolus with placebo
Cefotaxime is administered as bolus q.i.d. with a placebo of paracetamol
干预措施: Bolus without paracetamol (Drug)
结局指标
主要结局
Day 7 Mortality
时间窗: On day 7 from the institution of treatment
All patients who had received at least one dose of treatment and were dead on day 7 from the institution of treatment on day 1.
次要结局
- All Deaths During Hospital Stay(The outcome was assessed each day until the patient was discharged from the hospital. The longest hospital stay was 84 days, while the last death occurred 39 days after treatment initiation.)
- Status on the Modified Glasgow Outcome Scale(Examined at discharge from hospital, except for hearing evaluations which were performed at earliest seven days since the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.)
- Death or Any Neurological Sequelae on Day 7(Examined on day 7 since institution of treatment.)
- A Change in Hearing Threshold Compared to the First Test Result(Hearing thresholds obtained during any of the first three days after hospital admission were compared with hearing thresholds obtained on day seven or later, during the hospital stay. The longest hospital stay was 84 days.)
- Death or Severe Neurological Sequelae on Day 7(Examined on day 7 since institution of treatment)
- Number of Participants With Deafness(This outcome includes hearing thresholds determined at earliest seven days after the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.)
- Death or Any Neurological Sequelae at Discharge From Hospital.(Examined at discharge from hospital. The longest hospital stay was 84 days.)
- Death or Severe Neurological Sequelae at Discharge(Examined at discharge from hospital. The longest hospital stay was 84 days.)
研究者
Heikki Peltola, MD, PhD
Profesor
University of Helsinki