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Malaria clinical trials

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NCT ID: NCT00666380 Completed - Malaria Clinical Trials

A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya

Start date: April 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.

NCT ID: NCT00663546 Completed - Malaria Clinical Trials

Malaria Studies in Cambodia

Start date: March 24, 2008
Phase:
Study type: Observational

This study, conducted by the National Center for Parasitology, Entomology and Malaria Control of Cambodia s Ministry of Health and the National Institute of Allergy and Infectious Diseases, will explore whether the following factors confer protection against malaria and associated anemia: certain blood groups, the hemoglobin E variant, G6PD-deficiency and alpha-thalassemia. Malaria is caused by parasites (P. falciparum and P. vivax) that are transmitted to humans through mosquito bites. This protocol includes two studies, a cohort study and a P. vivax collection study. Individuals are eligible for enrollment in the studies as follows: Cohort study: Residents of all ages of Kandal, Ekapheap and Sangkumthmey villages (Thmar Da commune) who plan to remain in Thmar Da commune for the next 5 years. P. vivax collection study: 2 years of age and older Participating in NIAID protocol 05-I- N210 ( Severe Malaria and Anti-malarial Drug Resistance in Cambodia ) and diagnosed with P. vivax malaria Participants undergo the following procedures: Cohort study: Baseline evaluation, including the following: - Collection of demographic information - Malaria history, temperature measurement and review of current symptoms, if any - Blood draw of 300 microliters - Additional blood draw of 10 milliliters in selected adults 18 years of age and older Treatment with artesunate-piperaquine at a commune health post for subjects who develop malaria Contact once a year for 5 years to determine continued residency in Thmar Da commune P. vivax collection study: - Medical history and physical examination - Hemoglobin level measurement - Blood draw - Treatment with chloroquine - Blood draw 3 to 5 weeks after treatment in some patients 18 years of age or older

NCT ID: NCT00658450 Completed - Malaria, Cerebral Clinical Trials

Rehabilitation Program for Cognitive Deficits in Ugandan Children After Cerebral Malaria

Start date: February 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether computerised cognitive rehabilitation training improves cognition in children who have had cerebral malaria.

NCT ID: NCT00652275 Recruiting - Malaria Clinical Trials

Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine

Start date: May 2008
Phase: Phase 2
Study type: Interventional

This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults and twice in children proved to be safe in all three occasions for this phase IIb study in children to proceed. This study will include children who will be randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide or the Verorab control. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be followed-up for immediate reactions to vaccination, extended safety profile and immunological response associated with protection from malaria. These children will be followed up for over a longer term of two years. Blood will be taken to evaluate the biological safety parameters and also the immune responses.

NCT ID: NCT00639873 Completed - Malaria Clinical Trials

Artemisinin Resistance in Bangladesh

Start date: June 2008
Phase: N/A
Study type: Interventional

A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.

NCT ID: NCT00623857 Completed - Malaria Clinical Trials

Micronutrients and Child Health Study

MACH
Start date: March 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young Tanzanian children.

NCT ID: NCT00623155 Completed - Malaria Clinical Trials

Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali

Start date: July 2002
Phase: N/A
Study type: Interventional

Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.

NCT ID: NCT00616304 Suspended - Clinical trials for Severe Falciparum Malaria

Safety and Preliminary Efficacy of L-arginine in Severe Falciparum Malaria

ARGISM
Start date: February 2008
Phase: Phase 2
Study type: Interventional

Background: Mortality from severe malaria remains ~15% despite the use of the most rapidly parasiticidal antimalarial therapy, artesunate. Adjunctive treatments may improve outcome. Our overall goal is to determine if adjunctive treatment with L-arginine is safe and improves outcomes in severe malaria. In studies to date, we have shown that L-arginine is safe in moderately severe malaria, increases nitric oxide production and improves endothelial function. We now propose to extend these studies to patients with severe malaria. Aims: To determine the safety, preliminary efficacy, pharmacokinetics and pharmacodynamics of L-arginine infusion in severe malaria. Hypothesis: L-arginine will improve endothelial function, lactate clearance time and tissue oxygen delivery compared to saline with no clinically significant adverse effects. Methods: Based on previous pharmacokinetic modeling and simulations, we propose a phase 2A randomised controlled trial of L-arginine vs saline in severe malaria, each given over 8 hours. If safety is demonstrated this will be followed by a phase 2B open-label study of 24-hour infusion of L-arginine in severe malaria with safety and preliminary efficacy compared with the 8 hour infusions given in phase 2A. The primary outcomes will be the improvement in endothelial function and lactate clearance in patients given L-arginine infusion compared with those who received saline. Among the secondary outcomes will be safety and the effect of L-arginine vs saline on tissue oxygen delivery (NIRS). Data from both phase 2A and 2B will be used to generate a pharmacokinetic/ pharmacodynamic model.

NCT ID: NCT00612547 Completed - Fever Clinical Trials

ACT for the Home Management in Malagasy Children

Start date: February 2008
Phase: N/A
Study type: Observational

The purpose of this study is to assess the feasibility, the acceptability and the effectiveness of the use of the Artesunate + Amodiaquine Fixed Dose Combination for the home management of presumed malaria in Malagasy children by the community-based service providers.

NCT ID: NCT00593398 Completed - Clinical trials for Plasmodium Falciparum Malaria

Malarial Immunity in Pregnant Cameroonian Women

Start date: September 2008
Phase:
Study type: Observational

Malaria is caused by a parasite and is a health problem for mothers and fetuses (unborn infants). The Cameroonian Ministry of Health recommends that all pregnant women should take the drug sulfadoxine-pyrimethamine (also known as SP) every two months during pregnancy to avoid malaria. The purpose of this study is to find out how effective SP is in preventing pregnant Cameroonian women from getting malaria. Additional goals of this study are to see whether: SP prevents malaria parasites from causing changes in the placenta; SP prevents or helps women make a substance that keeps parasites from accumulating in the placenta; and whether SP affects the amount of protection a mother transfers to her baby. Participants will include 1,160 pregnant women, ages 15-50 years, and 216 babies born residing in Ngalii II and Ntouessong. Study procedures will include monthly blood samples from pregnant women and babies. Volunteers may participate in this study for up to 19 months.