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Malaria clinical trials

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NCT ID: NCT02089841 Completed - Clinical trials for Plasmodium Falciparum Malaria

Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.

ALE
Start date: May 2012
Phase: Phase 4
Study type: Interventional

Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated malaria since 2007. Nonetheless, a report of increased proportion of patients with parasitaemia on day 1 following treatment with artemisinin based combination therapies has emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria among children after five years of wide scale use of the drug in Tanzania.

NCT ID: NCT02083887 Completed - Malaria Clinical Trials

A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants

VAC058
Start date: February 2014
Phase: Phase 1
Study type: Interventional

Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a safe and effective vaccination strategy against malaria. The vaccines have been found to be well tolerated when tested in Gambian adults, young children and infants, who are at risk of severe malaria. Both vaccines will be given to participating infants at the same time as some EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still helpful in making the body's defense system respond.

NCT ID: NCT02083406 Completed - Malaria Clinical Trials

Bioavailability Study of Oral OZ439 Prototype Formulations Administered With Piperaquine Phosphate (PQP)

Start date: July 2014
Phase: Phase 1
Study type: Interventional

A single dose study to investigate how different formulations of OZ439 co-administered with PQP tablest are processed by the body when taken without food

NCT ID: NCT02083380 Completed - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Phase IIb Study to Investigate the Efficacy of OZ439 & Piperaquine Phosphate Co-administered to Adults & Children With Uncomplicated Plasmodium Falciparum.

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

A randomised, double-blind single-dose (loose combination) study in patients with uncomplicated Plasmodium falciparum malaria. The study will test for efficacy/futility through analyses, using Bayesian methodology. Adults and children will be included through progressive step-down in age following safety analyses. This study investigates the efficacy exposure-response of OZ439/PQP combination in the target populations and if it meets its efficacy objectives, will inform dose setting for Phase III studies.

NCT ID: NCT02083068 Completed - Malaria Clinical Trials

Evaluation of the Protective Efficacy of a Vaccine Derived From the Synthetic CS Protein of Plasmodium Vivax

Start date: August 2014
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) who were made 3 immunizations with a synthetic derivative of the CS protein of Plasmodium vivax in order to determine their protective efficacy. Then volunteers will be subject to an infectious challenge to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.

NCT ID: NCT02080026 Completed - Malaria Clinical Trials

Target Antigens Induced by Plasmodium Falciparum Sporozoite Immunization Under Chemoprophylaxis

BMGF1
Start date: June 2014
Phase: N/A
Study type: Interventional

Malaria, a disease caused by the parasite Plasmodium, is one of the world's major infectious diseases. With approximately 627.000 deaths a year, there is desperate need for an effective vaccine. Though a number of vaccine-candidates have been developed, they have yet to achieve the level of efficacy necessary to eliminate malaria. It has been shown previously that healthy human volunteers bitten by malaria-infected mosquitoes while taking chloroquine, medicine that prevents malaria, are fully protected against a subsequent malaria challenge. This is called CPS-immunization. The unprecedented effectiveness of CPS-immunization makes it a good model to identify what immune responses protect against malaria, to further guide vaccine development. In this study we will use CPS-immunization to induce protection against malaria in healthy subjects and then analyse their immune response to a malaria challenge infection.

NCT ID: NCT02072629 Completed - Malaria Clinical Trials

HCU: Can VHVs Trained in ICCM Improve Care for Children

HCU:VHV/ICCM
Start date: November 2009
Phase: N/A
Study type: Interventional

This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children. In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?

NCT ID: NCT02052323 Completed - Malaria Clinical Trials

Harmonized AS/MQ Efficacy Study - Thailand

Start date: October 2013
Phase: Phase 4
Study type: Interventional

The purposes of this study is to determine parasitological clearance rates by microscopy for the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum malaria.

NCT ID: NCT02044198 Completed - Clinical trials for Plasmodium Falciparum Malaria

A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria

Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate an experimental malaria vaccine for its ability to prevent malaria infection or disease in a blood-stage challenge model (when volunteers are infected with malaria parasites using malaria-infected red blood cells). The vaccine being testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve the body's response to a vaccination) called AS01B. The aim is to use this protein and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will enable assessment of: 1. The ability of the vaccine to prevent malaria infection. 2. The safety of the vaccine in healthy participants. 3. The response of the human immune system to the vaccine. This will be done by giving participants three vaccinations and then exposing them to malaria infection by transfusing a small number of red blood cells infected with malaria under carefully regulated conditions. Participants will be followed closely to observe if and when they develop malaria. If the vaccine provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all. The study will enrol 15 participants to be vaccinated and then challenged with malaria in addition to recruit 15 individuals to be control subjects.

NCT ID: NCT02043652 Completed - Malaria Clinical Trials

Plasmodium Vivax Efficacy Trial in Cruzeiro do Sul, Acre, Brazil

Start date: February 2014
Phase: N/A
Study type: Interventional

Background: The World Health Organization recommends that antimalarial treatment policies be evaluated every few years to check their efficacy. P. vivax malaria is the most common species in Brazil and cases are concentrated in the Amazon Region in Brazil. Objectives: Assess the efficacy of chloroquine and primaquine for the treatment of P. vivax infections in Cruzeiro do Sul, Acre, Brazil. Methods: An in vivo drug efficacy study will be conducted in Cruzeiro do Sul, Acre State, Brazil. At least 117 study participants ≥5 years of age with parasitologically confirmed P. vivax monoinfections will be treated under supervision with chloroquine (CQ) for three days at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National Malaria Control guidelines. For patients with normal glucose 6 phosphate dehydrogenase activity levels, investigators will add primaquine at dose of 0.5mg/Kg per day for 7 days. Clinical and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and for a total period of 168 days (6 months) to evaluate chances of recrudescence, relapse, or reinfection. Blood samples will be taken to measure the CQ levels in blood on Day 7 and day of failure, if occurring in the initial 28 days of follow up. In addition, a blood sample will be collected on filter paper on first day and on day of suspected failure to help differentiate parasite genotypes using techniques based on polymerase chain reaction. Results from this drug efficacy study will be used to assist the Brazilian Ministry of Health in assessing their national malaria treatment policy for P. vivax malaria.