TES Artemether-lumefantrine for Pf and Chloroquine (CQ) for Pv
Status:
Completed
Trial end date:
2018-12-30
Target enrollment:
Participant gender:
Summary
Purpose: To assess the efficacy of the current first line of treatment policy.
Objectives:
To assess the safety and efficacy of Artemether-lumefantrine for the treatment of
uncomplicated P. falciparum infections in the Philippines.
To assess the efficacy of Artemether-lumefantrine for the treatment of P. vivax infections in
the Philippines.
Study Sites:
Rural Health Unit, Bataraza, Palawan Rural Health Unit, Rizal, Palawan
Study Design: one-arm, prospective study
Patient Population: Febrile patients aged > 6 months to 59 years old, with confirmed
uncomplicated P. falciparum infection only or P. vivax infection only, and non- pregnant
and/or breastfeeding for female.
Sample Size: A minimum of 50 and maximum of 75 patients will be enrolled for both Plasmodium
falciparum and Plasmodium vivax malaria.
Treatments and follow-up: Clinical and parasitological parameters will be monitored over a
28/34 day follow-up period to evaluate drug efficacy.
Primary endpoints: The proportion of patients with early treatment failure, late clinical
failure, late parasitological failure or an adequate clinical and parasitological response as
indicator of efficacy. Recrudescence will be distinguished from re-infection by polymerase
chain reaction (PCR) analysis.
Secondary endpoints: The frequency and nature of adverse events.
Optional exploratory endpoints: to determine the polymorphism of molecular markers for name
of the antimalarial drug(s) resistance.
Phase:
N/A
Details
Lead Sponsor:
Research Institute for Tropical Medicine, Philippines
Collaborator:
World Health Organization
Treatments:
Artemether Artemether, Lumefantrine Drug Combination Chloroquine Chloroquine diphosphate Lumefantrine