View clinical trials related to Malaria.
Filter by:First-in-Human, Randomised, Dose-Finding Single Center Study to evaluate three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel® : 3 µg, 10 µg and 30 µg
In Nigeria, malaria is the commonest reason for outpatient clinic attendance in childhood and is responsible for about 20% of childhood deaths. The emergence of strains of P. falciparum resistant to chloroquine and sulfadoxine-pyrimethamine led to severe worsening of morbidity and mortality from malaria. As a result of resistance to previously used monotherapy, the World Health Organization (WHO) in 2001, recommended that malaria-endemic countries experiencing drug-resistant malaria infection adopt combination therapy. Artemisinin-based combination therapy (ACT) is preferred to the non-ACT combination. In this randomized open-label clinical trial, the safety and efficacy of pyronaridine-artesunate and artemether-lumefantrine in the treatment of malaria among children aged 3 to 144 months who have microscopically confirmed symptomatic Plasmodium falciparum malaria were compared. The study was carried out at the Oni Memorial Children's Hospital, Ring Road Ibadan. One hundred and seventy-two children between 3 and 120 months who meet the inclusion criteria will be enrolled after obtaining written or witnessed signed informed consent from the parents or guardian. A detailed history and physical examination were carried out on each enrollee. Finger prick blood samples were taken from each enrolee for thick blood smear for malaria parasite, haematocrit, and blood spots on filter paper. Five millilitres of venous blood will be taken from an arm vein for baseline liver function tests, creatinine, and random blood glucose on days 0, 3, 7 and 28. Enrollees were randomized into one of two groups. Group one received pyronaridine-artesunate while group two received artemether-lumefantrine at standard doses. Enrollees were seen daily from days 0-3, and on days 7, 14, 21 and 28. Study drugs were administered supervised at standard dosage on days 0, 1, and 2. History taking, physical examination and blood smears were done at each contact time. Special attention will be paid to adverse effects. Parasite clearance time, fever clearance time and cure rates were compared between the two groups.
We describe a Type II hybrid effectiveness-implementation study design which evaluates the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the drugs used. The study consists of three components: 1) Conducting a cluster randomized controlled trial (cRCT) through household surveys establishing confirmed malaria cases in children; 2) Conducting a prospective cohort study to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine and amodiaquine (SPAQ) and whether drug concentrations or parasite resistance influence the duration of protection; and 3) Conducting a resistance markers study in children 3-59 months to measure changes in resistance marker prevalence over time.
This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children.
This observational research study aims to answer the question: 'Which aspects of human biology play an important role in recovery from symptomatic malaria?' In particular, the researchers aim to identify human genes for which the level of gene activity reflects the patient's overall rate of recovery. The researchers believe this approach may reveal new targets for adjunctive therapies. The researchers aim to recruit 240 people, of all ages, who have been diagnosed with symptomatic malaria at selected hospitals in London. Blood samples, urine samples, and clinical information will be collected over the 14 days following malaria diagnosis.
The objectives of this study contains 3 parts: (1) a comparison of 1-step parenteral artesunate (AS) versus conventional 2-step parenteral artesunate in patients with severe malaria to assess the feasibility of administration, parasite and fever clearance times in two countries, (2) a quantification of convenience and costs of the new 1-step artesunate parenteral formulation versus the conventional formulation in a randomised study, (3) A cost analysis of 1-step parenteral artesunate using data from Part 1 & Part 2. This will assess health facility-level costs, and also health system costs to encompass all costs of a potential change from conventional to 1-step artesunate, including re-training, materials, and drug replacement. The conventional formulation of injectable artesunate requires a 2-step reconstitution and dilution of the artesunate hemisuccinate powder. A new formulation of injectable artesunate has been developed by Fosun Pharma requiring a simpler 1-step reconstitution. Bioequivalence of the new formulation to the conventional formulation. For part 1, a total number of participants of this study would be 200 participants, estimated 100 per site will be recruited. For part 2, a total number of 40 semi-structured interviews with study staff, health staff, policy makers, and stake holders; and survey/questionnaires with 150 health staff.
Background: Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person. Objective: To assess in African adults the safety of and immune response to the administration of Pfs230D1-EPA/Matrix-M vaccine as compared to the rabies vaccine control. Eligibility: Healthy adults (18 to 50 years of age) who reside in Sotuba and surrounding villages in Mali Design: Participants will be screened with: - Medical history - Physical exam - Blood, urine, and heart tests - Malaria comprehension exam Participants will be randomly assigned to get either the experimental vaccine or the approved rabies vaccine. They will not know which they are getting. Participants will get 3 doses of the study or comparator vaccine via injection in the upper arm. This occurs at the first visit, 1 month, and 2 months later. Participants will have up to 23 scheduled visits over 14 to 16 months. Each visit includes a physical exam, and blood will be collected at most visits. Participants will be followed up to 1 year after the final vaccination. If participants develop an injection site rash or reaction, photographs may be taken of the site.
This is a household randomized trial of a new tool for house modification, Insecticide-Treated Eave nets (ITENs) in combination with insecticide-treated window screens (ITWS), coated with a dual active ingredient (dual AI): Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m² and PBO synergist at 10g/kg which corresponds to 480 mg/m², as used in the so-called dual-AI LLIN or "resistance breaking" nets for resistance malaria vector control. Four hundred and fifty (450) households with intact walls, opened eaves, and those without screens or nets on the windows in Chalinze district, Tanzania will be eligible and only recruited upon written informed consent. The households will be randomly allocated into two arms: one with ITENs and ITWS installed and the other without. The primary outcome will be malaria parasite detection in household residents aged over 6 months old using a quantitative Polymerase Chain Reaction (qPCR) at approximately 12 months post-installation, coinciding with the long rainy season.
Last Mile Health (LMH) has partnered with the Liberian Ministry of Health (MOH) to support the design and implementation of the National Community Health Assistant Program (NCHAP). In collaboration with MOH, LMH is planning to conduct an impact evaluation in Grand Bassa to assess the effect of the National Community Health Assistant Program (NCHAP) on health outcomes, as well as to learn lessons around program operations and implementation. Our central hypothesis is that Community Health Assistants (CHAs) within the NCHAP will reduce under 5 mortality, as a result of expanding access to and uptake of health care utilization in remote communities. We will use a mixed effects discrete survival model, taking advantage of the staggered program implementation in Grand Bassa districts over a period of 4 years to compare the incidence of under-5 child mortality between the pre- and post-CHW program implementation periods.
This stepped-wedge cluster-randomized controlled trial with nested mixed methods study will assess the effectiveness, acceptability, feasibility and cost-effectiveness of a personal protection package to reduce malaria transmission among mobile and migrant populations (MMPs) and the general population in their residing villages in Lao People's Democratic Republic (PDR) and Cambodia.