A Study to Evaluate Intravenous Artesunate to Treat Severe Malaria in the United States

Overview

About this study

The purpose of this study is to make available intravenous artesunate for treatment of severe malaria in U.S. hospitals because parenteral quinidine is no longer available.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Malaria confirmed by microscopy. It is expected that the great majority of the eligible cases will diagnosed as P. falciparum.
  • Patients with other microscopic diagnoses of malaria (Plasmodium of undetermined species, or species other than falciparum) will also be eligible, taking into account the unfamiliarity of some U.S. laboratories with malaria diagnosis and the importance of timely treatment of severe malaria.
  • In exceptional cases, microscopic diagnosis might be waived; e.g., a patient with strong clinical suspicion of severe malaria, for whom a timely, reliable microscopic diagnosis is not available (current CDC guidelines advise that in such cases, parenteral antimalarial treatment is justified).
  • Parenteral treatment required due to one or more of the following reasons:
    • Unable to take oral medications; or 
    • High density parasitemia (>5%); or
    • Severe malaria based on:
      • Impaired consciousness.
      • Seizures.
      • Circulatory collapse/shock.
      • Pulmonary edema or acute respiratory distress syndrome (ARDS).
      • Acidosis.
      • Acute renal failure.
      • Abnormal bleeding or disseminated intravascular coagulation (DIC).
      • Jaundice.
      • Severe anemia (Hb < 7 g/dL).

Exclusion Criteria:

  • Known allergy to artesunate.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Lake City, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Mankato, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Owatonna, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Red Wing, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

La Crosse, Wis.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Cannon Falls, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Eau Claire, Wis.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Albert Lea, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

Austin, Minn.

Mayo Clinic principal investigator

Muhammad Sohail, M.D.

Contact us for the latest status

Contact information:

Muhammad Sohail M.D.

(507)255-7938

Sohail.Muhammad@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available