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Malaria clinical trials

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NCT ID: NCT02769013 Completed - Clinical trials for Malaria Transmission

Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity

TRANSMAL
Start date: April 2016
Phase:
Study type: Observational

Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity.

NCT ID: NCT02758353 Completed - Malaria Clinical Trials

The Impact of Sulphadoxine-Pyrimethamine Use At Scale on Newborn Outcomes in Nigeria

MIPP-NG
Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility of the scale-up of sulphadoxine- pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the introduction of community-based distribution of SP in addition to ongoing health facility distribution during antenatal care (ANC) visits. In addition, the study examined for the effect of SP use by participants during pregnancy on the head circumference of live newborns and on the odds of a baby being a stillborn. Finally, the investigators also sought to quantify the costs associated with program scale up SP to deliver at least three doses of SP per participant via a government operated distribution program.

NCT ID: NCT02751294 Completed - Malaria, Vivax Clinical Trials

A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled Solution

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This study will investigate the effect of Tafenoquine (TQ) 150 mg tablet ageing (dissolution profiles) on human exposure of TQ comparing the relative bioavailability of TQ from tablets exhibiting different dissolution profiles in healthy subjects. This is a single-centre, 2-arm, randomized open-label, parallel-group study in healthy subjects. All subjects will arrive in the unit approximately 24 hours prior to dosing and will be discharged after the 72-hour post-dose assessments are completed. Subjects will return for outpatient visits on Days 7, 14, 21, 28, and 56 after dosing. A total of 14 subjects (n=7 subjects in each arm) are planned to be enrolled. All subjects will receive a single dose of study medication (2x150 mg TQ tablets + 30 mg TQ SIL in solution) and participate through a 56-day post dose follow-up visit. To enable the application of peripheral microsampling in planned paediatric studies, a comparison of the measured pharmacokinetic (PK) exposure via peripheral blood collection (via microsampling) to venous collection will also be performed in this study.

NCT ID: NCT02742285 Completed - Malaria Clinical Trials

Lumefantrine in Venous Plasma Versus Dried Capillary Blood Spot

Start date: May 2016
Phase: Phase 4
Study type: Interventional

Measurement of the concentration of antimalarials in the blood of the general population helps estimating the overall drug pressure and is used in efficacy studies. The current sampling standard for drug measurement is plasma obtained by venous puncture. The use of a Dried Blood Spots (DBS) sampling strategy can make some aspects of field trials conditions easier, but concordance with usual venous sampling is not yet established. The current work will allow validating the concentrations of lumefantrine measured in the DBS samples collected during the field trials and validate the use of DBS for future studies. In addition, bearing in mind the substantial deployment of artemether-lumefantrine combinations supplies throughout most malaria endemic countries, this study may improve our understanding of lumefantrine and artemether distribution in the blood compartments and generate knowledge for further developing analytical methods for drug measurement. The overall purpose of this study is to validate the dried blood spots as a sampling method for the analysis of lumefantrine. The primary objective is to assess the concordance between lumefantrine plasma and dried blood spots (DBS) concentrations. The investigators also aim at describing lumefantrine's distribution in the different blood compartments: binding to plasma proteins, total in plasma, inside the red blood cells, total in whole blood.

NCT ID: NCT02739763 Recruiting - Malaria Clinical Trials

Controlled Human Malaria Infection in Semi-Immune Kenyan Adults. (CHMI-SIKA)

CHMI-SIKA
Start date: May 2016
Phase: Phase 1
Study type: Interventional

The investigators wish to understand how resistance to malaria develops and how this affects the growth rate of malaria in individuals who have past exposure to malaria.

NCT ID: NCT02737007 Completed - Malaria, Falciparum Clinical Trials

A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607

Start date: April 18, 2016
Phase: Phase 1
Study type: Interventional

This is an open-label, single-centre, non-randomized study to investigate the pharmacokinetics of GSK3191607, administered as a single intravenous (IV) dose in healthy male subjects. Six subjects will be administered an IV microdose of radio-labeled [14C]-GSK3191607. The study will provide an early readout on human pharmacokinetic parameters. The results of this study will be used to estimate the potential duration of anti-parasite effect in humans, define predicted clinical oral doses, and hence inform about the compound's potential safety margin. Each subject will participate in the study for up to 8 weeks, and will have a screening visit, one treatment period, eight outpatient visits, and a follow-up visit.

NCT ID: NCT02721420 Recruiting - Malaria Clinical Trials

Delivery of Malaria Chemoprevention in the Post-discharge Management of Children With Severe Anaemia in Malawi

PMC
Start date: March 24, 2016
Phase: Phase 3
Study type: Interventional

Background and rationale: Children hospitalised with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No strategy specifically addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect was in addition to the effect of insecticide-treated bednets. There is now need to design and evaluate effective delivery mechanism for PMC within the health system.

NCT ID: NCT02721186 Completed - Malaria Clinical Trials

Effectiveness of Mass Drug Administration for Reducing Seasonal Malaria Transmission in Zanzibar

MaDrAZ
Start date: April 30, 2016
Phase: N/A
Study type: Interventional

The overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar.

NCT ID: NCT02708199 Completed - Malaria Clinical Trials

Molecular Assessment of Drug Resistance Markers in Asymptomatic Malaria Cases and Malaria Antibody Kinetic

Start date: January 2015
Phase: N/A
Study type: Observational

Detection of the drug resistance molecular markers for falciparum and vivax in Longitudinal follow-up samples collected in Shwegyin Township, Bago Region that is Artemisinin Resistance Containment Tier I.

NCT ID: NCT02704533 Completed - Malaria Clinical Trials

Sequential Optimization of Dose and Schedule of PfSPZ Vaccine

Start date: August 29, 2016
Phase: Phase 1
Study type: Interventional

MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization with PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10^5, 1.35x10^6, or 2.7x10^6 PfSPZ per dose and a total dose between 2.7x10^6 and 8.1x10^6 PfSPZ followed by CHMI with 3,200 fully infectious PfSPZ (PfSPZ Challenge). PfSPZ Challenge (7G8) to assess vaccine efficacy, safety, tolerability and infectivity of ascending PfSPZ doses will be assessed in healthy, malaria-naïve volunteers.