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Malaria clinical trials

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NCT ID: NCT02001012 Completed - Clinical trials for Uncomplicated Knowlesi Malaria

P. Knowlesi Trial of Artemether-lumefantrine vs Chloroquine

CAN KNOW
Start date: January 2014
Phase: Phase 3
Study type: Interventional

Preliminary studies have supported the background efficacy of local standard anti-malarial medications in the treatment of uncomplicated knowlesi malaria, however there are no current WHO treatment guidelines for this infection. There are both health cost benefits to a more rapidly acting agent, and due to difficulties with microscopic identification there may be more effective treatment for all malaria species if an aligned treatment guideline could be supported. We are currently conducting a separate RCT using a similar protocol evaluating artesunate-mefloquine versus chloroquine for uncomplicated P. knowlesi malaria. However artemether-lumefantrine should also be compared against chloroquine due to the fact it is also a first line anti-malarial recommended in Malaysia, and there are potential differences in efficacy due to the different administration, absorption and half-life of artemether-lumefantrine. The investigators aim to test whether the fixed combination of artesunate-mefloquine is superior to chloroquine in order to define the optimal treatment for both uncomplicated P. knowlesi infection in both adults and children in this region.

NCT ID: NCT01994525 Completed - Malaria Clinical Trials

Immunization Via Mosquito Bite With Radiation-attenuated Sporozoites

IMRAS
Start date: January 24, 2014
Phase: Phase 1
Study type: Interventional

This study is to assess the safety, tolerability, and biomarkers of protection in healthy malaria-naïve adults, who will receive bites from Anopheles stephensi mosquitoes either infected with Plasmodium falciparum Sporozoites (PfRAS) (true-immunization) or noninfected (mock-immunization).

NCT ID: NCT01992900 Completed - Malaria,Falciparum Clinical Trials

A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria

Start date: November 2013
Phase: Phase 2
Study type: Interventional

There is a need for paediatric formulations that permit accurate dosing and enhance patient compliance. However, for the treatment of malaria, scarce paediatric-friendly formulations are available on the market. Thus, a new water dispersible formulation of eurartesim has been developed for oral administration. Aim of this study is to provide data on pharmacokinetic profile, safety and efficacy of this new paediatric formulation and compare it with the crushed film coated tablet in infant patients (6 to ≤12 months of age) suffering from uncomplicated Plasmodium falciparum malaria. Furthermore, a Pharmacokinetic/Pharmacodynamic(PK/PD) modelling will be built up to establish PK/PD relationship in adult and paediatric populations.

NCT ID: NCT01988636 Completed - Malaria Clinical Trials

Study of Safety and Effectiveness of Intravenous Immunization With PfSPZ Vaccine in Healthy African Adults

Start date: October 29, 2013
Phase: Phase 1
Study type: Interventional

Background: - Malaria is caused by small germs carried by mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells and reduces oxygen in the blood. Most malaria is mild, but severe malaria kills at least 660,000 people each year. About 75% of these are children in Sub-Saharan Africa, most under age 5. Researchers want to find a safe vaccine that helps prevent malaria. Objectives: - To see if a new malaria vaccine is well tolerated and effective. Eligibility: - Healthy adults 18 35 years old who are not pregnant and live in Mali. Design: - Participants will be screened with medical history, physical exam, and blood test. They will also have an ECG. Soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals. - Study participation will last about 1 year. - Participants will be randomly placed in 5 groups. Some will get 2 doses of the PfSPZ vaccine weeks apart; some will get 3 or 5 doses of vaccine; some will get 3 or 5 doses of placebo. - Doses will be given through a needle in the arm directly into the bloodstream. Then participants must stay at the clinic for 2 hours. - After each dose, participants will return to the clinic several times for blood tests and physical exam. - A week before the first dose and 2 weeks after the last, participants will take a full course of anti-malaria drugs. - If a participant gets malaria during the study, they will take another course of anti-malaria drugs.

NCT ID: NCT01982812 Completed - Epilepsy Clinical Trials

A Dose-Escalation, Safety and Feasibility Study of Enteral LVT for Seizure Control in Pediatric CM

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

Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

NCT ID: NCT01976780 Completed - Malaria Clinical Trials

In Vivo and In Vitro Efficacy of Artemisinin Combination Therapy

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

This study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ).

NCT ID: NCT01976416 Completed - Malaria Clinical Trials

Novel Use Of Hydroxyurea in an African Region With Malaria

NOHARM
Start date: September 2014
Phase: Phase 3
Study type: Interventional

Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute painful episodes and reducing the need for blood transfusions in children with sickle cell anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan Africa, the areas with the most children with SCA. The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for children with SCA in a malaria endemic region within sub-Saharan Africa.

NCT ID: NCT01972321 Completed - Malaria Clinical Trials

ICCM of Common Childhood Diseases: Mozambique and Uganda

inSCALE
Start date: April 2013
Phase: N/A
Study type: Interventional

The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses

NCT ID: NCT01967472 Completed - Malaria Clinical Trials

Adherence to Antimalarial Drugs in Sierra Leone

Start date: September 16, 2013
Phase: N/A
Study type: Interventional

The aim of this study is to address this gap in knowledge by measuring the level of patient adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key factors that influence adherence. This will be addressed through a mixed methods study that will provide not only a measurement of adherence ACTs and malaria test results, but will also provide contextual information in order to better understand factors that affect adherence. Data will be collected through a series of interviews with health workers and parents/caregivers and through observations of patient-provider consultations. The first stage of the study begins with semi-structured interviews and observations of patients/caretakers' consultations with health workers and will look at how health workers diagnose and treat malaria. This will be followed by short exit interviews at the health facility with caregivers to assess patient satisfaction with services, as well as to test the consistency between the data obtained through structured observations and the exit interviews. Follow-up surveys at the homes of patients will be used to measure and compare the adherence of participants to two different ACTs (AQAS and AL) formulations and potential factors that affect adherence. Additionally, data will be collected using in-depth interviews to collect supplementary information in order to discover, in more detail, factors that may affect behavioral choices and/or attitudes with regard to adherence.

NCT ID: NCT01958905 Completed - Malaria Clinical Trials

Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children

MAL-NUT
Start date: November 2013
Phase: N/A
Study type: Interventional

The general objective of the study is to answer to the question: "Is the current dose of AL less efficacious in the severely malnourished compared to the non-severely malnourished children, and is PK in cause?" We aim to assess whether the current treatment dose is adequate for children with severe acute malnutrition, and we hope results will guide further recommendations for malaria treatment in this specific population.