View clinical trials related to Malaria, Falciparum.
Filter by:Despite preventive programs, effective case management is still the cornerstone in malaria control. This study is as a strategy towards improved recommendations in resource limited countries during artemether -lumefantrine (AL) treatment in order to maximize the public health benefits. This is observational population pharmacokinetics study with a nested comparative bioavailability study.The study is intended to describe the variability in lumefantrine blood levels among under five year old Ugandan children with uncomplicated falciparum malaria receiving current standard artemether-lumefantrine dose regimens. Findings will form a basis for development of rational dosage recommendations. The nested comparative bioavailability study will explore effect of profiled local food intake (maize porridge plus vegetable oil versus milk) on lumefantrine uptake. As a strategy towards improved recommendations in resource limited countries during AL treatment in order to maximize the public health benefits. As a secondary objective we will correlate the variability in lumefantrine uptake to malaria treatment outcome and safety profile in this population. Research hypotheses 1. The population pharmacokinetic profile of lumefantrine among under five year old children in Uganda with uncomplicated falciparum malaria is not affected by demographic factors. 2. There is no difference in the bioavailability of lumefantrine when artemether-lumefantrine is received with maize porridge plus vegetable oil versus milk among under five year old Ugandan children treated for uncomplicated falciparum malaria.
Phase IV, single center, 2 arms randomized controlled, open label study. Study will be conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics and efficacy of ARCO.
This is a clinical trial in which healthy volunteers will be administered experimental malaria vaccines. One group of volunteers will receive vaccination with the leading malaria vaccine candidate, RTS,S/AS01. This vaccine schedule will consist of 3 doses of RTS,S/AS01 with an interval of 4 weeks between doses (Doses given at 0,4 and 8 week timepoints). Another group will receive a vaccination schedule composed of the same dosage and timing regimen of RTS,S, but they will also receive vaccination with ChAd63 ME-TRAP, 2 weeks after the first RTS,S followed 8 weeks later by vaccination with MVA ME-TRAP (2 and 10 week timepoints). The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples. Volunteers will be infected with malaria by mosquito bites, 12 weeks after the first vaccination. In addition, a group of volunteers not receiving vaccines will also be infected with malaria by the same method. These infection experiments will be used to assess vaccine efficacy: how well the vaccines act to prevent malaria disease. A further single volunteer may also be infected with malaria; this volunteer participated in a previous trial where they received vaccines and was completely protected against malaria disease after infection by mosquito bite. The RTS,S/AS01 vaccine is a protein (RTS,S) mixed with an adjuvant (AS01). The ChAd63 ME-TRAP and MVA ME-TRAP vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they can not multiply. The viruses have extra DNA in them so that after injection, the body makes malaria proteins (but malaria does not develop), so that the immune system builds a response to malaria without having been infected by it. Healthy volunteers will be recruited in England at three research sites: in Oxford, London and Southampton.
The overall aim of this study is two fold: 1. to pilot targeted chemo-elimination of plasmodium falciparum malaria in known areas of artemisinin resistance in South East Asia. 2. to understand the micro-epidemiology of malaria in these areas; chiefly, the prevalence and importance to on-going transmission of sub-clinical p.f malaria infections.
This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or without single-dose primaquine in patients with uncomplicated Plasmodium falciparum malaria. On the last day of DP therapy, volunteers will be randomized to receive either a single 45 mg dose of primaquine (PQ) or DP treatment only (no primaquine).
The aim of the study was to follow clearance of malaria infections and detection of new malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children during 42 days.
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609
Background: - Malaria is an illness caused by a parasite spread by mosquitoes. When a mosquito bites a person who is infected with a kind of parasite called a gametocyte, it is able to spread the infection to another person. Not everyone infected with parasites have gametocytes in their blood. As a result, not everyone can spread malaria to others. Researchers are interested in learning more about why some healthy people have gametocytes in their blood and others do not. Identifying the people who have gametocytes in their blood can help target treatment and reduce the spread of malaria. This study will focus on the people of the village of Kenieroba in Mali, where malaria is common. Objectives: - To study the relationship between gametocytes and malaria transmission in Mali. Eligibility: - Individuals between 6 months and 65 years of age who live in Kenieroba, Mali, and will stay in the area for 1 year. Design: - For 1 year, participants will have study visits once every 2 weeks (twice a month, for a total of 24 visits). The visits will last 30 minutes each. - At each visit, participants will provide a small blood sample. They will report any symptoms of malaria such as fever, headache, and body aches. Participants will be encouraged to seek medical treatment if they experience malaria symptoms between visits. - Participants who have malaria symptoms will have a blood test for malaria parasites. Those who have parasites in the blood will receive antimalarial treatment. - Three times over 1 year, a larger blood sample will be collected. These blood samples will be taken once in the dry season, once in the wet season, and once in the next dry season. - Women between 14 and 45 years of age will also provide urine samples to test for pregnancy. Pregnant women will not be asked to give blood samples.
This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.
Study treatments: - Artemether-lumefantrine - Artesunate-amodiaquine - Dihydroartemisinin-piperaquine Location: Maradi, Niger Principal Objective: To measure the clinical and parasitological efficacy of the three artemisinin combination therapies over a period of 42 days from the start of treatment and with polymerase chain reaction assay (PCR) adjustment. Secondary objectives: - To determine the blood concentration of the non-artemisinin component of the treatment (lumefantrine, desethylamodiaquine or piperaquine) at day 7 - To assess the incidence of adverse events during the follow-up period; - To measure speed of parasite clearance Methods: In vivo non comparative study as for WHO standardised protocol. The study also measure the concentration of the non-artemisinin component. Target population: Children under 5 years of age consulting the integrated health centres of Andoumé and Dix-sept portes in Maradi. Sample size: 221 patients per study treatment; 663 patients in total. Treatment allocation: Random. Outcomes: - Early treatment failure, - Late clinical failure, - Late parasitological failure, - Adequate clinical and parasitological response. Analysis: - Cumulative success or failure rate (Kaplan-Meier analysis). - Proportions of early treatment failures, late clinical failures, late parasitological failures, and adequate clinical and parasitological response (called also Per-protocol analysis).