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Very Severe Malaria Treated by Intravenous Artesunate

NCT04516317 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 578

Last updated 2022-03-24

No results posted yet for this study

Summary

In endemic areas, Plasmodium falciparum malaria exacts a huge public health toll, causing close to half a million deaths each year. In non-endemic industrialized areas, imported malaria may develop. In France, around 5000 imported cases occured annually, including 10-15% of severe malaria.

The criteria for defining severe malaria in endemic areas are established by the World Health Organization (WHO), and have been adjusted for severe imported malaria. In France, in order to optimize management, severe imported malaria is separated into two groups: very severe malaria (VSM) and less severe malaria (LSM). Briefly VSM included coma and/or shock and/or respiratory failure and/or acidosis and/or hyperlactatemia and/or death during hospitalization.

In France, severe imported malaria is treated with intravenous artesunate. Little is known about the management of imported VSM in the ICU with intravenous artesunate.

In a French national multicentric retrospective frame, the main objective of the present study is to describe in detail: epidemiology, management, outcome and prognostic of very severe imported malaria treated with intravenous artesunate during the period 2011-2019. The second objective is to retrospectively compare two groups : VSM treated with intravenous artesunate in the ICU during 2011-2019 versus VSM treated with intravenous quinine in the ICU during 2000-2010.

Conditions

  • Severe Malaria

Interventions

OTHER

None (Observational study Group intravenous artesunate)

Retrospective descriptive study of Group intravenous artesunate

OTHER

None (Observational study Group intravenous quinine)

Retrospective descriptive study of Group intravenous quinine

Sponsors & Collaborators

  • Dr Fabrice BRUNEEL

    lead OTHER

Principal Investigators

  • Fabrice BRUNEEL, MD · Versailles Hospital Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2022-03-15
Completion
2022-03-22

Countries

  • France

Study Locations

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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 NCT04516317 on ClinicalTrials.gov