Impact of Improved Diagnostic Tools, Training and Communication on Acute Fever Case Management and Antibiotic Prescriptions for Children and Adolescents Presenting at Outpatient Facilities in Lower & Middle-Income Countries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17,294
- 试验地点
- 14
- 主要终点
- Proportion of acute febrile cases with favorable clinical outcomes at day 7
研究概览
简要总结
This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) rapid diagnostic tests, and behaviour change interventions in cases of acute febrile illnesses in children, adolescents and adults presenting at out patient clinics in lower and middle income countries. The study is to be implemented in 2 phases- the first run from 2020 to 2021 and the 2nd phase from 2021 to 2022 to include COVID-19 PoCTs.
详细描述
Background and rationale. 'Just-in-case' antibiotic prescribing practices is one of the causes of inadequate management of 'acute febrile illnesses' and AMR in Low- and Middle-income Countries (LMICs). At the same time, some people who would require antibiotic treatment do not get it. An improvement in case management and prescription practice might lead to a decrease in morbidity and mortality. Success will mean making significant steps toward achieving the dual goal of improving UHC and tackling AMR.
The PICO question addressed is: in children/ adolescents and adults (Population) presenting to outpatient clinics / peripheral health centres in LMICs with acute febrile illness/Respiratory Tract Infection can a combination of available PoC rapid diagnostic tests, diagnostic aids/algorithms, clinic process flow and, training and communication (Intervention) improve management of acute febrile illnesses and better target the use of antibiotics / reduce unnecessary antibiotic prescriptions (Outcomes) compared to current practice (Control)?
Primary objective(s).
To evaluate the impact of a package of interventions (point of care [PoC] tests, clinical algorithm, clinic process flow, training and communication tools) on clinical outcomes and antibiotic prescriptions, with standard-of-care practices, in children and adolescents presenting with acute febrile illnesses (defined as fever with no focus or Respiratory Tract Infection lasting for no more than 7 days), at outpatient clinics.
Secondary objective(s)
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with fever with no focus/RTI:
- •Children (6 months to <12 years) and adolescents (12 years to less than 18 years old) of both sexes .
- •Presenting with an acute febrile illness defined as temperature of >37.5°C or history of fever within the last 7 days with no focus or suspected RTI.
- •Parent/guardian providing written informed consent for their children if less than 18 years of age.
- •Obtain assent for adolescent between 12 and less than 18 years old
- •Willing to provide blood and other samples and adhere to study procedures explained in the consent forms following the protocol.
- •Available and willing to return for follow-up visit at the health facility on day 7 (+/- 2 days).
排除标准
- •o Children and adolescents from 6 months to less than 18 years old presenting with chronic febrile illness (fever lasting more than 7 days).
- •Patients with acute febrile illness outside the allowed age range for the site.
- •Severely ill patients requiring hospital admission or referral as assessed by the study clinicians.
- •Anyone refusing consent to the study or not able to attend the health centre for follow-up (adults, the children of parents/guardians, or adolescents who refuse or are missed when asking for consent).
结局指标
主要结局
Proportion of acute febrile cases with favorable clinical outcomes at day 7
时间窗: Day 7
Favorable defined as being alive and asymptomatic.
Antibiotic prescription rates in acute fever cases
时间窗: Day 0
Proportion of antibiotic prescriptions for acute febrile illness in the clinic
次要结局
- Proportion of study participants who adhered to antibiotic prescriptions(Day 7)
- Proportion of participants with acute fever Diagnoses identified by point of care tests.(Day 0)
- Adverse events(Day 7)
- Time spent in the clinic(Day 0)