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Malaria clinical trials

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NCT ID: NCT00811356 Terminated - Malaria Clinical Trials

A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria

Start date: December 11, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if the study drug (antimalarial medication) is safe when given to healthy subjects as a single dose or as repeated doses, to understand the effect of food on single doses of study drug and to determine if the study drug has an effect on other approved medications such as rosiglitazone and rosuvastatin.

NCT ID: NCT00739206 Terminated - Malaria Clinical Trials

Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.

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

The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria. The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.

NCT ID: NCT00711906 Terminated - Clinical trials for Malaria in Pregnancy

Daily Co-trimoxazole Prophylaxis to Prevent Malaria in Pregnancy

Start date: February 2009
Phase: Phase 3
Study type: Interventional

Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women and children are the most vulnerable population. Malaria in pregnancy increases the risks of abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia are recommended. HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV infected persons, and CTX prophylaxis significantly improves birth outcomes in immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we aim to establish the safety and efficacy of daily CTX in preventing malaria infection during pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This information is urgently needed to assist to issue guidelines on IPT in pregnancy.

NCT ID: NCT00497471 Terminated - Anemia Clinical Trials

RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

Start date: February 1995
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

NCT ID: NCT00453856 Terminated - Malaria Clinical Trials

Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

Start date: March 2007
Phase: Phase 4
Study type: Interventional

IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi. In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium, and to provide information for policy makers regarding the predicted efficacy of IPTi, it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted. The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the "in vivo efficacy study," which follows a standardized World Health Organization protocol. A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage and/or spread of drug resistant P. falciparum parasites. Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear.

NCT ID: NCT00400101 Terminated - Falciparum Malaria Clinical Trials

Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides

Start date: November 2003
Phase: Phase 1
Study type: Interventional

Influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. The aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides derived from the circumsporozoite protein and from the apical-membrane-antigen 1 and that the formulations are safe in humans.

NCT ID: NCT00386750 Terminated - Malaria Clinical Trials

Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function

Start date: June 2005
Phase: Phase 4
Study type: Interventional

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function.

NCT ID: NCT00374205 Terminated - Malaria, Falciparum Clinical Trials

Randomized Trial on Effectiveness of ACTs in Ghana

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

The purpose of this study is to compare the effectiveness and safety of two Artemisinin Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium falciparum malaria

NCT ID: NCT00361114 Terminated - Malaria Clinical Trials

IPT and Efficacy of Sulphadoxine/Pyrimethamine and Chlorproguanil/Dapsone in 6-59 Month Old Children With Malaria.

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

Intermittent Preventive Treatment of malaria in infants is a promising strategy to reduce incidence of clinical malaria in children under the age of 1 year. It is likely to be implemented as a malaria control strategy in Tanzania using sulfadoxine/pyremethamine SP. SP is failing as a first line treatment for clinical episodes of malaria and government policy is driving a change to use Artemesin Combination Therapy (ACT). The main ongoing Kilimanjaro IPTi study is looking at alternatives to SP for use in IPTi. Currently, as there is no evidence for the use of other drugs for IPT, SP will be continued for IPT in pregnancy and in infants. This study proposes to measure the efficacy of SP and chlorproguanil/dapsone (CD), in symptomatic 6- 59 month old children using standard methodology. These are both study drugs in the main IPTi study. This will help us to see how the efficacies of SP and CD in sick children relate to the efficacies for treating asymptomatic children with IPTi. In addition this proposal aims to test the efficacy of SP given to 2-10 month old asymptomatic infants (the target group for IPTi). Evidence suggests that asymptomatic malaria infections with low parasitaemia have a higher cure rate than symptomatic infections with high parasitaemia even when markers of resistance are highly prevalent. This second study aims to quantify this difference and will produce evidence to help policy makers know when drugs used for IPTi should be changed. Both studies will be open label and run concurrently in Hale, Korogwe district near to the main Kilimanjaro IPTi site in Tanzania.

NCT ID: NCT00341783 Terminated - Malaria Clinical Trials

Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Don gu Bougou, Mali

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

There are about 300-500 million cases of malaria worldwide each year, with 2-3 million deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these deaths. Because of increasing resistance of this parasite to drugs and of mosquitoes to insecticides, a vaccine would be valuable in the fight against malaria. Don gu bougou, Mali, is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines. The goal of this study is to characterize the population of this site in terms of common hematologic (blood) and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials. The study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy. Also, the natural immunity to antigens in the investigational malaria vaccines will be determined. Don gu bougou, Mali, was chosen because of its high malaria rates. Data will be collected at four time-points. At least 50 individuals will be recruited from each of the following age groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. Village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected. Individual consent will also be obtained. Enrolled volunteers will undergo a baseline medical history and physical examination. Blood will be collected for various tests, and, for women of childbearing age, urine pregnancy tests will be administered. At each of three followup visits, a brief medical history and physical exam will be conducted. Blood will be drawn for tests. Also, blood, urine, and/or stool tests not done at baseline will be done at one of the followup visits.