Community Access to Rectal Artesunate for Malaria (CARAMAL): Observational Research in Nigeria, Uganda and DR Congo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,758
- 试验地点
- 3
- 主要终点
- Proportion of children <5 years with severe febrile illness seen by CHW/primary HF that resulted in death within 28 days
研究概览
简要总结
Many malaria deaths occur in places where people have poor access to preventive and curative health services. Prompt access to quality health services is critical in the case of severe childhood diseases, among which severe malaria is particularly frequent in endemic areas. In communities where parenteral treatment of severe malaria is not available, the World Health Organization (WHO) recommends administration of a single rectal dose of artesunate (RAS) to children less than 6 years, followed by immediate referral to an appropriate facility where the full package of care for severe malaria can be provided.
Many African countries have already endorsed the use of pre-referral RAS. But treatment guidelines vary widely across these countries and often do not align with the WHO recommendation. With the impending availability of quality-assured rectal artesunate (QA RAS) and countries poised to scale-up this intervention, it is critical to investigate the safe and effective implementation of RAS as part of a continuum of care for severe malaria patients. To ensure that RAS is well targeted, it is equally urgent to learn more about frequency, treatment seeking and risk factors for severe malaria at community level. The CARAMAL project has two major components: the pilot implementation of QA RAS in selected areas of the Democratic Republic of the Congo (DRC), Nigeria and Uganda, and operational research on the introduction of QA RAS into established integrated community case management (iCCM) platforms. The CARAMAL project is funded by Unitaid and coordinated by the Clinton Health Access Initiative, Inc. (CHAI). UNICEF is responsible for QA RAS implementation. Swiss TPH in partnership with the local research organizations Akena Associates Ltd. in Nigeria, Kinshasa School of Public Health in DRC and Makerere University School of Public Health in Uganda carries out the operational research component to generate evidence for the responsible implementation of RAS. Finally, the CARAMAL project will generate a better understanding of severe febrile illness, its management at all levels and key determinants of health outcomes.
详细描述
Objective(s):
The overall goal of the CARAMAL project is to contribute to reducing malaria mortality in children globally by improving the community management of suspected severe malaria cases. The project will contribute to this goal by advancing the development of operational guidance to catalyse effective and appropriate scale-up of QA RAS as pre-referral treatment of severe malaria.
Accompanying the pilot roll-out of QA RAS by UNICEF, the CARAMAL project will test whether it is feasible to introduce QA RAS into established integrated community case management (iCCM) platforms with only minimal additional supportive interventions and with minimal unintended consequences such as inappropriate use as artemisinin monotherapy.
Through the research activities described in detail below, the CARAMAL project aims to answer the following research questions:
I. What are the minimal requirements of a community case management system to ensure that RAS is an effective part of the continuum of care from the community to a referral facility (defined as a health care facility equipped for inpatient care of severe malaria)?
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient surveillance system:
- •Children < 5 years
- •History of fever plus danger signs indicative of severe febrile illness / suspected severe malaria, according to local iCCM guidelines
- •Child referred to higher level facility by CHW/primary health facility, or, child directly attending a referral facility.
- •Signed full consent form from parent / guardian
- •Health care provider interview:
- •CHW or health worker at peripheral health facility enrolled in the iCCM referral system who treats children < 5 years OR
- •Health care provider at referral hospitals treating children < 5 years OR
- •Any other health care provider in project area treating children < 5 years
- •Signed consent form
- •Household survey:
- •Household head and parent / caregiver of children < 5 years
- •Signed consent form from parent / guardian
排除标准
- •Patient surveillance system:
- •Children ≥ 5 years
- •Children with no permanent residence in project area
- •Health care provider interview:
- •Health workers not treating children < 5 years
- •Health workers outside project area
- •Health workers who do not speak any of the local languages
- •Health workers employed since < 1 month
- •Household survey:
- •Parents / guardians with no children < 5 years
- •Parents / guardians with no permanent residence in project area
- •Parents / guardians who do not speak any of the local languages
结局指标
主要结局
Proportion of children <5 years with severe febrile illness seen by CHW/primary HF that resulted in death within 28 days
时间窗: From RAS administration up to 28 days
Patient surveillance system (data collected at referral facility at 28 days visit including verbal autopsy)
次要结局
- Proportion of children <5 years with severe febrile illness seen by CHW/primary HF who completed referral(From RAS administration up to 28 days)
- Proportion of children <5 years with severe febrile illness without parasites on day 28(28 days after RAS administration)
- Proportion of children <5 years with a recent history of fever (mild or severe) who attend CHW/primary HF(Through study completion, an average of 2 years)
- Number of children <5 years with severe febrile illness who report directly to referral health facility(Through study completion, an average of 2 years)
- Proportion of children <5 years with severe febrile illness managed pre-referral according to guidelines(Through study completion, an average of 2 years)
- Proportion of children <5 years with severe febrile illness managed post-referral according to guidelines(Through study completion, an average of 2 years)
- Frequency of passively reported adverse events after RAS administration(From RAS administration up to 28 days)
- Frequency of delayed haemolytic anaemia within 28 days after RAS administration(28 days after RAS administration)
- Proportion of trained and functional CHW and primary HF who provide QA RAS(Through study completion, an average of 2 years)
- Proportion of CHW/primary HF with RAS in stock(Through study completion, an average of 2 years)
- Proportion of referral health facilities that have the capacity to manage severe malaria in children in line with global guidance(Through study completion, an average of 2 years)
- Proportion of CHW/primary HF that received at least one supervisory visit in the past 3 months(Through study completion, an average of 2 years)
- Acceptability of pre-referral RAS among caretakers(Through study completion, an average of 2 years)
- Financial cost of RAS interventions per death averted(Through study completion, an average of 2 years)
- Acceptability of pre-referral RAS among health workers(Through study completion, an average of 2 years)
- Total financial cost of managing severe case at community level. Marginal financial cost of adding RAS to the management(From RAS administration up to 28 days)