MedTrace Logo

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

NCT02528279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Coartem

Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days. Tablets are available as a fixed dose combination of 20mg artemether plus 120mg lumefantrine. The dosing will be based on the body weight and follow the manufacturer's recommendations: Body weight 5-14kg: 1 tablet; Body weight 15-24kg: 2 tablets; Body weight 25-34kg: 3 tablets; Body weight \> 34kg: 4 tablets; The respective amount of tablets is to be taken at hours 0, 8, 24, 36, 48 and 60 with fatty food.

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Albert Schweitzer Hospital

    lead OTHER

Principal Investigators

  • Michael Ramharter, Prof. · Centre de Recherches Médicales de Lambaréné

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Gabon

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 NCT02528279 on ClinicalTrials.gov