Validation of an Assisted Medical Care Strategy Composed of a Clinical Decision Support System and RDTs to Reduce Antibiotic Prescription in Non-severe Acute Disease in Children 15 Years Old and Younger in Senegal
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 470
- 试验地点
- 4
- 主要终点
- Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7
研究概览
简要总结
This trial aims to validate a novel clinical care strategy based on a electronic clinical decision support algorithm (CDSA) combined with point of care rapid diagnostic tests by evaluating its impact on antibiotic prescription and clinical outcome of children and adolescent presenting at primary healthcare facilities with non-severe acute illness compared to routine practice. The trial also aims to assess the usability of the CDSA strategy. The study will be conducted in primary healthcare facilities across different epidemiological regions of Senegal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ongoing fever or diarrhea
- •ongoing fever will be defined objectively or as a reported fever, defined as : axillary temperature ≥37.5°C or tympanic, oral or rectal temperature ≥38.0°C; and fever duration ≤ 10 days
- •ongoing diarrhea will be defined as at least 3 abnormal stools during the last 24hrs
- •First consultation for the current illness
- •Feasibility of contact between the patient (or his/her designated relative) and the study team at day 3 and day 7
- •Written informed consent by the caretaker/legally acceptable representative
排除标准
- •Infants less than 6 months of age
- •Age ≥ 15 years
- •Clinical status requiring immediate transfer to an appropriate care facility/ severe illness
结局指标
主要结局
Non-inferiority of the CDSA strategy when compared to routine practice in terms of clinical status assessed at Day 7
时间窗: 4 months
This will be measured as point estimates of the percent change of patient with resolved illness at Day 7 in the intervention arm, as compared to the control arm.
Superiority of the CDSA strategy when compared to routine practice in terms of antibiotic prescription at Day 0
时间窗: 4 months
This will be measured as point estimates of the percent change of antibiotic prescription at Day 0 in the intervention arm, as compared to the control arm and to site-specific historical data. This measure aims to assess rational use of antibiotics using the CDSA strategy compared to routine practice.
次要结局
- Diagnostic performance of the dengue rapid diagnostic test (RDT)(4 months)
- Antibiotic prescription rate during 7 days of follow-up in the intervention arm compared to the control arm(4 months)
- Identification of risk factors associated with viral and bacterial infections(4 months)