Relapses in Plasmodium Ovale and Efficacy of Artemether-lumefantrine for Mixed Species and Non-falciparum Malaria

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Malaria is a protozoan infection transmitted by anopheline mosquitoes. The most severe forms are caused by Plasmodium (P) falciparum and to a much lesser extent by P. vivax.

Although the interest in research on malaria has increased during the last years, yet little research is conducted on the "neglected" malaria species P. ovale and P. malariae. P. ovale being first described in 1922, it still remains unclear whether it displays dormant pre-erythrocytic liver stages, so called hypnozoites, or not. Primaquine, the only marketed drug with liver stage activity at present, can cause severe hemolysis in glucose-6-phosphate dehydrogenase (G6PD) deficient persons and methemoglobinemia. Because G6PD is widely spread in Central Africa, it is important to explore whether additional intake of liver-active medication is really needed and on this account further research to investigating new treatment options with liver stage activity should be conducted.

While, due to widespread resistance, treatment recommendations for P. falciparum and mixed infections have switched from chloroquine to the safer applicable artemisinin-based combination therapies (ACTs), World Health Organization (WHO) guidelines still suggest chloroquine as first line treatment for P. malariae and P. ovale mono infections. Further studies assessing alternative treatment options are largely missing.

Summing up the current situation for both topics shows the need for further research. Therefore this study aims to assess the evidence and characterize the frequency of relapses in P. ovale infections with respect to differences between its subspecies as well as the effectiveness of the ACT artemether-lumefantrine in P. malariae and P. ovale mono- and mixed infections.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Schweitzer Hospital
• Collaborator: Medical University of Vienna
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

Criteria

Inclusion Criteria:

• Male or female patients older than 1 year

• Presence of uncomplicated malaria infection confirmed by: fever or history of fever in the previous 3 days, and positive microscopy of P. malariae, P. ovale or mixed infection with parasite density > 10 - 200000/µl of blood

• Residence in vicinity and no travel plans for the next 6 months

• Written informed consent by the patient or the legal representative and where possible, patient assent will be sought. If the patient/parent/guardian is unable to write, witnessed consent is permitted according to local ethical considerations.

Exclusion Criteria:

• Presence of P. falciparum monoinfection

• Presence of severe malaria (clinical WHO criteria)

• Presence of other febrile conditions

• Known history of hypersensitivity, allergic or adverse reactions to artemether or lumefantrine

• Intake of any antimalarials or antibiotics with known antimalarial activity in the past 72 hours

• Intake of an 8-aminoquinoline antimalarial or atovaquone-proguanil in preceding 28 days

• Pregnant women in first trimenon