Last Updated

02 Aug 2019

Community Access to Rectal Artesunate for Malaria (CARAMAL)

Objectives

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:

  1. 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)?
  2. What are the unintended consequences of scaled implementation, such as adverse drug reactions, unforeseen costs, or unforeseen issues in treatment of malaria at all levels of care, and how can they be addressed?
  3. Is there any use of RAS beyond the recommended guidelines, including full treatment of severe cases with RAS at community level, and the treatment of uncomplicated malaria with RAS?
  4. Can the introduction of pre-referral QA RAS reduce severe malaria case fatality ratio over time under real-world operational circumstances in three distinct settings?
  5. What are the costs and cost-effectiveness of community and peripheral health facility based RAS?
Funding Information
This project is being supported by Medicines for Malaria Venture (MMV) through a Unitaid supply grant
Rationale and Abstract

Rectal artesunate is a pre-referral intervention for children under 6 years of age, which when properly administered has the potential to reduce risk of death or permanent disability by up to 50%. In situations where patients with severe malaria do not have immediate access to injectable artesunate/a referral center, the World Health Organization (WHO) recommends giving children in this age group a single rectal dose of artesunate and referring immediately to an appropriate facility where the full management of severe malaria can be provided. Until recently, the lack of a quality-assured product and limited operational guidance meant few countries had successfully introduced this pre-referral intervention in accordance with the WHO recommendation. 

ClinicalTrials.gov Identifier: NCT03568344

Study Design
Study Type  : Observational
Estimated Enrollment  : 6032 participants
Observational Model: Other
Time Perspective: Prospective

Date

2018 Jun - 2020 Oct

Funding Details