NCT05294510已完成不适用
STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,280
- 试验地点
- 1
- 主要终点
- Antibiotic prescriptions at baseline visit
研究概览
简要总结
This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda.
The purpose of this study is to assess the impact of the algorithm on antibiotic use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 months-5 years
- •Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature > 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate > 30) OR cough
排除标准
- •Age > 5 years or < 2 months at time of presentation
- •Guardian not present to provide consent
结局指标
主要结局
Antibiotic prescriptions at baseline visit
时间窗: Baseline visit
Proportion of children prescribed antibiotics by the village health worker at the baseline visit in the control as compared to the intervention condition.
次要结局
- Unexpected visits(Between baseline visit and Day 7 follow-up assessment)
- Perceived improvement per caregiver(Day 7)
- Clinical Failure (Composite Outcome)(Between baseline visit and Day 7 follow-up assessment)
- Persistent fever(Day 7)
- Development of danger signs(Between Day 1 and Day 7)
- Hospitalization(Between Day 1 and Day 7)
- Death(Between Day 1 and Day 7)
- Antibiotic prescriptions during study follow-up(Between baseline visit and Day 7 follow-up assessment)
研究者
研究点 (1)
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