View clinical trials related to Malaria.
Filter by:MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and safety of various dose schedules and formulations of GSK Biologicals' candidate malaria vaccine (RTS,S/AS01E) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study (follow-up to MALARIA-092 [NCT03162614] study) is to evaluate if protection can be extended with an additional Fx booster dose and if unprotected subjects can be protected following a Fx booster dose. In this booster study, subjects from MALARIA-092 (NCT03162614) study who completed vaccination and challenge will receive a Fx booster dose of RTS,S/AS01E and undergo a second controlled human malaria infection (CHMI) three to four weeks after vaccination. Additionally, subjects will be newly enrolled and will only undergo the sporozoite challenge as infectivity controls.
The TESTsmART Trial consists of two main aims. The overall goal of the two aims is to investigate the impact of malaria rapid diagnostic test (mRDT) subsidies and conditional artemisinin combination therapy (ACT) subsidies on the testing and treatment behavior of participants seeking care for their febrile illness in the private retail sector. Conditional ACT subsidies are discounts on quality-assured ACTs which are linked to the results of a malaria rapid diagnostic test administered at the retail outlet; only participants with a positive test will have access to an additional discount on a quality-assured ACT. The main objective of Aim 1 of this study is to identify a combination of conditional ACT and RDT subsidies that maximizes the proportion of participants that choose to have a malaria diagnostic test before taking a drug. The investigators will test two levels of conditional ACT subsidy (100% subsidy versus ~67% subsidy) and two levels of RDT subsidy (0% subsidy and 50% subsidy) in a factorial designed experiment. Because dose size and therefore the price of an ACT course are dependent upon patient age, the ACT subsidy amount will also be scaled with patient age. These subsidy levels were chosen to keep the estimated program cost of the combined subsidy within $0.30-0.60 USD per person (assuming 100% testing uptake and between 20-40% of participants having a positive RDT). These estimates represent an upper bound since testing is unlikely to reach 100%. Current subsidy levels for ACT costs the program between 1.30-2.50 USD per treatment, with more than a third of that investment spent on individuals without malaria. Individuals presenting to a retail outlet for a treatment of a fever or suspected malaria illness will be randomized to one of the four groups in equal proportions. A total of 840 participants will be enrolled (210 per arm). Their choices concerning uptake of testing and drug purchase will be recorded. The main outcome will be the proportion of participants that choose to take a test. Secondary outcomes include the proportion of participants who adhered to the results of the RDT among those who were tested (used ACT when positive and did not use an ACT when negative or without a test). The results of this study will be used to inform the subsidy levels in the intervention for Aim 2 of this trial.
The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.
The general objective of this study is to assess the therapeutic efficacy and safety of artesunate + amodiaquine combined with a single low dose of primaquine (0.25 mg/kg) for the treatment of uncomplicated P. falciparum malaria patients in Zanzibar. The specific objectives are: - To determine the clinical and parasitological efficacy of artesunate + amodiaquine and primaquine in the treatment of uncomplicated Plasmodium falciparum infection. - To differentiate recurrent infections during follow-up, i.e. recrudescence from new infections, by polymerase chain reaction (PCR). - To evaluate the incidence of adverse events, particularly with regards to potential hematological adverse events of primaquine. - To determine the polymorphism of molecular markers associated with artesunate + amodiaquine tolerance/resistance. - To formulate recommendations, which will enable the Zanzibar Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated or not. - To determine efficacy rate of the first line treatment compared to the first efficacy trial thirteen years ago.
The primary objective of the study was to determine the PCR-APCR up to day 42 in children <60 months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+ amodiaquine (ASAQ) or artemether-lumefantrine (AL; Coartem®). Secondary objectives included: clinical and laboratory assessment of drug tolerability and safety, evaluation of possible correlation between drug bioavailability and clinical outcome, comparison of efficacy data with the pre-implementation "ACO I" study, parasite and fever clearance, gametocyte carriage, and possible selection of mutations related to quinoline resistance.
The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or Coartem®. Secondary objectives were to determine safety and possible selection of mutations related to the resistance of the tested drugs.
Background: The disease malaria affects many people in Liberia and other parts of Africa. It is caused by germs that are spread by mosquito bites. It may be mild but can be serious or can lead to death if not diagnosed and treated. Children younger than 5 years old and pregnant women are most at risk of malaria. Worms also infect many people in Liberia. They can be caused by mosquito bites or by touching soil or still water. Worm infections can be mild or serious. Doctors in Liberia and their NIH partners want to learn more about these diseases in women and children. Objective: To measure how much malaria and worm infections there are in pregnant women and children in two counties of Liberia. Eligibility: Pregnant women ages 18 and older and children ages 6 12 months seeking routine care at C.H. Rennie Hospital or the Duport Road Health Center Design: Participants will be screened with questions about their health or their child s health. Participants will be asked further questions about their health and about their home life. Participants will give a small amount of blood by finger prick. This will be tested to see if they have malaria or some types of worms, and for research studies. Participants who are sick from malaria will be treated at a study clinic. Treatment will follow standards of the Liberia and/or the World Health Organization.
Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in African infants. Current malarial control strategies are threatened by emergence of parasite resistance to drug treatment and resistance of the mosquito vector to certain insecticides. A deployable malaria vaccine is therefore a key strategy for reducing malaria mortality and progressing towards global eradication, but those in clinical trials are currently someway short of WHO targets. ChAd63 ME-TRAP and MVA ME-TRAP are leading candidate vaccines being developed by Adrian Hill's group at the University of Oxford, and collaborators. Since 2007, testing of these vaccines intramuscularly in over 900 volunteers has shown them to be safe, well tolerated and capable of delivering partial efficacy against malaria infection. This study will be the first time studying the efficacy of giving a boosting dose of the vaccines intravenously in what the investigators call a "prime-target" strategy. It follows very encouraging pre-clinical work showing this route can target desirable immune responses to the liver to fight a crucial stage of malaria infection. An ongoing recent phase I study is dose escalating both these vaccines intravenously as a single dose prior to commencing this trial where intramuscular and intravenous doses will be combined for the first time. The investigators will initially recruit 46 healthy UK adult volunteers who will be enrolled into 4 vaccination arms (10 volunteers each) and an unvaccinated control group (6 volunteers) who will undergo a controlled human malaria infection (CHMI). These are standardised, carefully supervised infection experiments used internationally to assess vaccine efficacy. As this is the first time giving intramuscular and intravenous doses of these vaccines in a combined schedule, the investigators will closely profile the safety and immune response during the vaccination follow-up. All trial activity will take place in Oxford.
This was a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P. falciparum sporozoite infection model. Healthy men and women, aged 18 to 45 years were to be enrolled in 3 study cohorts and to be administered either P218 or placebo twice, 48 hours apart. Subjects in cohorts 2 and 3 were to be inoculated with P. falciparum sporozoites. Enrolment in cohorts was to proceed sequentially, to facilitate review of data by a Safety Review Team (SRT) before proceeding with a subsequent cohort. In cohort 1, safety and tolerability of P218 was assessed. In cohorts 2 and 3, chemoprotective activity of P218 against malaria infection was assessed, as well as the Influence of time of initiation of the P218 treatment on the protective effect.
In the current randomized trial, the investigators will test the ability of two experimental approaches to malaria infection management to reduce malaria transmission potential. Compounds in Saponé, Burkina Faso, will be randomized to 1 of 3 study arms: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced community case management (CCM), comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus monthly screening and treatment (MSAT) using RDTs. The study will be conducted over approximately 18 months covering two high transmission seasons and the intervening dry season