Intravenous artesunate now first-line treatment for severe malaria in the US
The Centers for Disease Control and Prevention (CDC) has announced that intravenous artesunate is now the first-line treatment for severe malaria infection in the US. The change in treatment protocol is due to intravenous quinidine, the only intravenous antimalarial drug currently approved in the US, being discontinued by the manufacturer. The CDC has highlighted that:
Intravenous artesunate is not currently approved by the Food and Drug Administration, and it is not commercially available in the US. From 1 April 2019, clinicians will need to call the CDC’s malaria hotline to obtain the drug via an expanded-use investigational new drug (IND) protocol. In cases where there is a delay in receiving the drug, the CDC recommends treating patients with an oral antimalarial (via nasogastric tube or after administration of an antiemetic) while waiting for the drug to arrive.
Intravenous artesunate is the first-line treatment currently recommended by the World Health Organization for the treatment of severe malaria, and has been for some years. Clinical studies have shown that it is safe and well tolerated, and can be used in infants and children, in the second and third trimesters of pregnancy, and during lactation. The benefits outweigh the risks of treatment in the first trimester of pregnancy.
There are approximately 300 cases of severe malaria diagnosed in the US each year, with most cases reported in people who have traveled from countries where malaria is endemic.
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In Western countries, almost all malaria occurs in travelers; therefore, the diagnosis may be missed if a history of travel is not elicited.
Patients typically present with nonspecific symptoms such as fever, chills, sweats, headache, and myalgia.
Examination of a Giemsa-stained blood film remains the diagnostic test of choice.
Once the diagnosis of malaria is confirmed, treatment should be started urgently, as a delay may be associated with disease progression and complications.
Management should be undertaken in conjunction with an infectious diseases specialist.
Malaria is a parasitic infection caused by protozoa of the genus Plasmodium. Five species are known to infect humans; Plasmodium falciparum is the most life-threatening. It is naturally transmitted to humans through a bite by an infected female Anopheles mosquito but may potentially be transmitted by blood transfusion or organ transplantation. It is widely distributed throughout tropical and subtropical regions, and the main burden of disease falls on these areas. Travelers account for the majority of disease in Western countries.
History and exam
- travel to endemic area
- inadequate or absent chemoprophylaxis
- insecticide-treated bed net not used in endemic area
- settled migrants returning from travel to endemic area of origin
- low host immunity (for severe disease)
- pregnancy (for severe disease)
- age <5 years (for severe disease)
- immunocompromise (for severe disease)
- older age (for severe disease)
- iron administration (children)
Consultant in Tropical and Travel Medicine
Hospitals for Tropical Diseases
London School of Hygiene and Tropical Medicine
RB is on the advisory board of Sigma Tau and on the Public Health England advisory committee for malaria prevention. His employer has received research payments from Sigma Tau. RB is an author of a number of references cited in this topic.
Dr Ron Behrens would like to gratefully acknowledge Mariyam Mirfenderesky, Dr Signe Maj Sorensen, Dr Joanna Allen, Dr Simon Warren, and Dr Behzad Nadjm, previous contributors to this topic.
MM, SMS, JA, and SW declare that they have no competing interests. BN is an author of a reference cited in this topic.
Head of the Travel Clinic
Consultant of Tropical and Travel Medicine
Swiss Tropical and Public Health Institute
BG has received a research grant from Novartis Pharma to assess the impact of the introduction of artemether-lumefantrine (Novartis) as first-line treatment for uncomplicated malaria on mortality of children under 5 years old in 2 districts in Tanzania and travel grants from Novartis Pharma to present the results of the study above. BG is an author of a reference cited in this topic.
Malaria Research Institute and Department of Molecular Microbiology and Immunology
Johns Hopkins Bloomberg School of Public Health
DS has received royalties from antigen provision for a diagnostic test to Inverness. DS with Johns Hopkins University has patents on diagnostic tests that do not require blood.
Institute of Specific Prophylaxis and Tropical Medicine
Medical University of Vienna
WHW declares that he has no competing interests.
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