View clinical trials related to Malaria.
Filter by:Malaria in pregnancy is a major cause of maternal and newborn morbidity and mortality in sub-Saharan Africa]. Effective antimalarial preventive and treatment regimens can significantly reduce malaria-related morbidity and mortality in the mother and baby. However, therapeutic choices are limited by concerns about possible toxicity to the fetus and because of these concerns pregnant women are normally excluded from clinical trials. This, combined with the lack of adverse events reporting system, results in a scarcity of data on drug safety and efficacy in pregnancy. Moreover, changes in the maternal physiology in pregnancy often alter the pharmacokinetic of drugs. Artemether-lumefantrine (ALN) is a highly efficacious artemisinin-based combination therapy approved by the World Health Organisation for use in the 2nd and 3rd trimesters, although it is still infrequently used in pregnancy and there is uncertainty as to the optimum dose. The pharmacokinetics of ALN are altered in pregnancy, resulting in reduced plasma concentrations and while the standard adult dose is still effective in high transmission settings, where pregnant women have higher levels of immunity, efficacy is reduced significantly in low transmission settings where women have lower levels of immunity. Inadequate antimalarial treatment dosing in pregnancy risks treatment failure or breakthrough infection and exposure of malaria parasites to sub-therapeutic drug concentrations thus selecting for drug resistance.
This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.
According to the World Malaria Report, there were significant decreases in the number of P.falciparum (PF) malaria cases worldwide in the past decade. On the Thai-Myanmar border where transmission is low and seasonal and where incidence of Multi-drugs resistant P.falciparum parasites is the highest, the same trend has been observed with a clear decline in malaria episodes and the ratio of P. falciparum/P. vivax (PF/PV. Economic development, unprecedented financial support, renewed efforts in vector control, a wider use of rapid diagnosic tests (RDTs) for malaria and the deployment of artemisinin based combination treatments (ACT) are the main contributing factors to those successes against malaria. However the emergence in Cambodia and on the Thai-Myanmar border of P.falciparum isolates that exhibit resistance to artesunate is threatening those gains . This is characterized by a slow parasite clearance rate observed in patients treated with artesunate. At the same time, recent SMRU surveys along the Thai-Burmese border using a new cutting-edge technology i.e. highly sensitive quantitative Real Time PCR (RT-PCR) able to detect very low parasitaemia (10 parasites per ml), found up to a 3-5 fold increase in the prevalence of malaria compared to what is found with the usual diagnostic tools such as microscopy, RDT or even conventional PCR. It seems that a large number of asymptomatic carriers with very low parasites counts (a large potential malaria reservoir) go undetected. If confirmed, this might pose the greatest obstacle for malaria elimination in the region and containment of artemisinin resistance. The purpose of the survey is to further study and understand the epidemiology of malaria in the refugee camp population using cutting-edge technology (RT-PCR) .
This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam. Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other. Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment. The results of the study will be used to inform malaria treatment guidelines in Viet Nam.
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.
Mass Drug Administration (MDA) and Mass Screening and Selective Treatment (MST) might be applied as strategies for eliminating malaria when focusing on transmission stages. Many studies either with MDA or MST has been done in low transmission areas demonstrated the impact of those activities to reduce malaria transmission. However, in high transmission such study is still very limited which is becoming the reason behind this study. A randomized cluster trial of MST study using dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara TImur province, Central Indonesia. There will be three arms in the study, i.e. (1) intervention arm of mass screening and treatment with interval of 6 weeks; (2) intervention arm of mass screening and treatment with interval of 3 months and (3) control arm without mass screening and treatment. The intervention arm with 6 weeks interval represents a new proposed method to detection malaria infections, while the intervention arm with 3 month interval represents the Ministry of Health current policy of active case detection in Indonesia, and the third arm will serve as the control for Ministry of Health's policy. The study will be conducted in 6 months period and evaluate various parameters including malaria incidence and proportion of anemia in monthly cohort school children (in arm1, 2 and 3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All positive subject in all arms will receive supervised treatment. Secondary objectives are the proportion of gametocytemia in the community, the proportion of malaria antibody of various age groups, population genetic of local parasite, submicroscopic incidence based polymerase chain reaction and the proportion of infective mosquitoes. Data analysis will be performed according to the method for cluster randomized trial evaluation.
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.
The primary objective of this study is to compare the bioavailability of two formulations (tablets and granules for dispersion) of the antimalarial drug pyronaridine-artesunate [3:1] (Pyramax, PA) in healthy adults. The secondary objective is to compare the safety of the two PA formulations and liver function test changes following the first and second administrations.
Background: - Malaria is a disease that is spread by mosquitoes. Researchers are looking for a vaccine that can prevent mosquitoes from transmitting malaria to people. They want to test a vaccine called Pfs25-EPA/Alhydrogel that may help stop malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people vaccinated from getting sick with malaria. Researchers want to test this vaccine in people who live in rural Mali. To do so, the study will compare the symptoms and the blood tests of the participants who receive either the study vaccine or a regular hepatitis B/meningococcal vaccine. Objectives: - To see if Pfs25-EPA/Alhydrogel is a safe and effective malaria vaccine. Eligibility: - Healthy volunteers between 18 and 45 years of age who live in Bancoumana, Mali. Design: - Participants will be screened with a medical history, physical exam, and blood tests. - Participants will be separated into two groups. One group will have Pfs25-EPA/Alhydrogel to test the study vaccine. The other group will have the regular Hepatitis B vaccine series, meningococcal vaccine. - In the study vaccine group, participants will have either a lower dose or a higher dose. For the lower dose, they will have two vaccine shots over 1 year. For the higher dose, they will have four vaccine shots over about 14 months. - In the other vaccine group, participants will have the Hepatitis B vaccine series, meningococcal vaccine according to the standard dose schedule. - All participants will provide regular blood samples for testing during the study. - Participants who develop malaria during the study will participate in evaluation of transmission and parasite development of malaria parasite from the person to mosquito via transmission assays. They will allow mosquitoes (that have no diseases) to bite them in a controlled clinic setting. This will let researchers see if the vaccine can stop the mosquitoes from carrying malaria to other people.
This study will be a single-center, phase I, randomized, open, in fed condition, parallel, single dose study to evaluate the pharmacokinetics and the safety, tolerability of Atovaquone/proguanil combination tablets and atovaquone suspension in Japanese healthy male subjects. Serial blood samples will be collected for the determination of the plasma concentration of atovaquone, proguanil and cycloguanil after dosing of atovaquone 1000mg/proguanil 400 mg and the plasma atovaquone concentration of atovaquone 750 and 1500 mg. Safety assessments will be performed for each treatment group. CYP2C19 contribute to proguanil metabolism. CYP2C19 genotype will be determined in atovaquone/proguanil dosing group.