Community Access to Rectal Artesunate for Malaria

NCT03568344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13758

Last updated 2022-02-17

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER
  • UNICEF

    collaborator OTHER
  • Kinshasa School of Public Health

    collaborator OTHER
  • Akena Associates Ltd.

    collaborator UNKNOWN
  • Clinton Health Access Initiative Inc.

    collaborator OTHER
  • Makerere University

    collaborator OTHER
  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Christian Burri, Prof · Swiss Tropical & Public Health Institute

  • Christian Lengeler, Prof · Swiss Tropical & Public Health Institute

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2020-08-31
Completion
2021-08-31

Countries

  • Democratic Republic of the Congo
  • Nigeria
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568344 on ClinicalTrials.gov