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Malaria clinical trials

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NCT ID: NCT00509015 Completed - Malaria, Falciparum Clinical Trials

Mass-Drug Administration to Reduce Malaria Transmission

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

In the 1950s, the WHO included mass drug administration (MDA) with antimalarial drugs as a tool for malaria control in 'exceptional conditions when conventional control strategies have failed'. Subsequently, MDA has received little attention until the introduction of artemisinin based combination therapy (ACT). The principle aim of MDA is to interrupt malaria transmission by clearing the population of sexual stage parasites, gametocytes, prior to the transmission season. Gametocytes are essential for propagation of the disease and elimination of gametocytes will result in a reduction in malaria transmission. As a consequence, a successful MDA will reduce the burden of disease in a population and is expected to have little influence on the development of protective immunity in areas of low transmission intensity. In Africa, only one large scale MDA study was conducted in the last 10 years. That study, conducted in The Gambia using sulphadoxine-pyrimethamine (SP) plus a single dose of artesunate (AS), failed to show a significant impact of MDA on malaria transmission. Possible reasons for this failure are the limited impact of the drug regimen (a single dose of AS) on malaria transmission, the incomplete coverage, the relatively high transmission intensity in the area and the migration of individuals between villages. Here, we propose to conduct an MDA study in an area of very low malaria transmission intensity in Tanzania. We use the highly active drug combination SP+AS (3 days) followed by a single dose of primaquine..

NCT ID: NCT00508417 Completed - Anemia Clinical Trials

Malaria Incidence in Infants in Bancoumana, Mali

Start date: July 24, 2007
Phase: N/A
Study type: Observational

This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in Bancoumana, Mali. Information from the study will help in planning trials of malaria vaccines. Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may be eligible for this study. Candidates are screened with a physical examination and blood tests. Participating children are visited at home for a total of about 17 visits to see if they are well. They come to the clinic every month during the 7-month study for a clinical evaluation, including a blood sample obtained by finger prick to test for malaria. Some of the blood collected may be stored and used for research. Children who become sick with malaria are treated for the disease.

NCT ID: NCT00499876 Completed - HIV Infections Clinical Trials

The Effect of Malaria on Disease Progression of HIV/AIDS

Start date: October 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether malaria affects how HIV/AIDS disease progresses in an infected patient, and to determine the effect of reducing malaria infection on HIV disease progression in Kumasi

NCT ID: NCT00495508 Completed - Malaria Clinical Trials

Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy

Start date: October 2006
Phase: Phase 4
Study type: Interventional

A) for the treatment of uncomplicated malaria during second and third trimester pregnancy to oral Quinine hydrochloride. The PCR-corrected adequate clinical and parasitological response (ACPR) on day 42 is considered as the primary efficacy criterion. Newborns will be followed for growth and development indicators.

NCT ID: NCT00493922 Completed - Malaria Clinical Trials

Trial of Rapid Diagnostic Tests in Rural Ghana

RDT
Start date: July 2007
Phase: Phase 4
Study type: Interventional

1) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).

NCT ID: NCT00493363 Completed - Falciparum Malaria Clinical Trials

Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia

Start date: June 2007
Phase: N/A
Study type: Interventional

There are worrying signs that parasitological responses to the artemisinin drugs for uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to artesunate are poor it is essential to have characterised the blood concentration profile as well as the parasitological response to differentiate resistance from abnormal pharmacokinetics. The primary objective of the study is to assess the level of resistance to artemisinin derivatives in Western Cambodia. A detailed evaluation of 2 different artesunate containing regimens in patients with uncomplicated malaria will be performed. Patients will be randomised to receive either a) Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').

NCT ID: NCT00489619 Completed - Pregnancy Clinical Trials

Safe Pregnancy by Infectious Disease Control

Start date: April 2004
Phase: N/A
Study type: Observational

Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and are important preventable causes of poor birth outcomes and maternal and infant mortality. This study investigated baseline characteristics of the population including: rates of STIs including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common antimalarial drugs.

NCT ID: NCT00487916 Completed - Malaria Clinical Trials

Phase 1 Study of the Safety, Reactogenicity, and Immunogenicity of AMA1-C1/ISA 720: Blood Stage Vaccine for Plasmodium Falciparum

Start date: June 13, 2007
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and effectiveness of a vaccine called AMA1-C1/ISA. Malaria is a serious infection of red blood cells caused by a parasite. There are 300 to 500 million malaria cases worldwide each year. About 2 to 3 million deaths annually are from malaria alone or along with other diseases. Researchers hope to find a vaccine to fight malaria. Patients ages 18 to 45 who are in good health, are not pregnant or breast feeding, have no history of malaria, and have not lived for more than 1 month in an area where malaria is prevalent may be eligible for this study. There will be 28 participants, each assigned to one of three dose groups: 12 get 5 microg, 12 get 20 microg, and 4 get 80 microg of AMA 1-C1 formulated in ISA 720. The vaccine might block the parasite from entering red blood cells and causing disease. This study is the first time the vaccine will be given to human beings for testing. Patients will have a medical history, physical exam, laboratory tests, and pregnancy tests. The study will last 48 weeks. One or two vaccinations are given by injection, at least 12 weeks apart. After each vaccination, patients will be asked to stay in the clinic for at least 30 minutes for observation. They will return to the clinic on Days 1, 3, 7, 14, 28, and 56 after each vaccination. There will be a check of vital signs, brief physical exam, history of symptoms and medications taken since the last visit, and blood tests to check for vaccine safety and effectiveness. Photographs of the injection site on the arm may be taken. Patients will receive a thermometer, diary card, and plastic measuring device. Each day they will record their temperatures and any symptoms, and measure the size of any reactions at the vaccination site. They will be asked to do this for 27 days after vaccinations. After injections, there may be pain, swelling, and redness at the vaccination site, and limitation of arm movement. General side effects from the vaccine may be fever, chills, headache, fatigue, and muscle and joint pain. Patients will be asked if they agree to have researchers keep any unused serum samples, for use only in research into malaria and other diseases. Genetic testing would not be done on those samples. Stored samples will be labeled with a code, and information is kept private.

NCT ID: NCT00486694 Completed - Malaria, Vivax Clinical Trials

Artesunate Plus Sulfadoxine-Pyrimethamine Versus Chloroquine for Vivax Malaria

Start date: March 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine whether the proposed first line treatment for falciparum malaria in this region (sulfadoxine-pyrimethamine + artesunate) would be no worse a treatment for vivax malaria that the standard vivax treatment of chloroquine. In areas where vivax and falciparum malaria co-exist misdiagnosis of vivax malaria as falciparum is not unlikely; it is important to know whether adequate treatment will be received in these cases.

NCT ID: NCT00484900 Completed - Clinical trials for Plasmodium Falciparum Malaria

Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

Start date: May 2006
Phase: Phase 3
Study type: Interventional

The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.