View clinical trials related to Malaria.
Filter by:The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.
In malaria-endemic areas, young children have an especially high risk of malaria morbidity and mortality. Malaria is estimated to cause up to 2 million deaths and 500 million clinical episodes in Africa alone. The bulk of disease in Africa and severe disease and deaths globally is due to P. falciparum. However, P. vivax is also responsible for a substantial disease burden in endemic regions outside Africa, where P. vivax may account for more than half of all malaria cases. Efforts to reduce this unacceptably high disease burden are hampered by the limited availability of affordable interventions. Following the cessation of large-scale vector control in highly endemic areas, malaria control efforts have centred on early diagnosis and treatment of clinical cases and reducing exposure through the use of insecticide-treated nets (ITNs). While ITNs have been shown to significantly reduce the burden of malaria additional effective interventions are urgently needed. Several trials have shown that chemoprophylaxis given to children at weekly or fortnightly intervals reduces morbidity from malaria in a number of different settings and populations. An alternative approach has been to use intermittent preventive therapy (IPT) involving the administration of a full therapeutic dose of antimalarials at regular intervals. This is logistically easier to deliver, and is less costly, and may reduce problems of promoting drug resistance associated with regular chemoprophylaxis. Intermittent administration of sulphadoxine-pyrimethamine (SP) during antenatal clinic visits was shown to be highly effective in reducing malaria and anaemia in pregnant women and improving infant birth weights. IPT in pregnancy (IPTp) is now recommended by WHO for endemic regions of Africa.
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and immunogenicity of 3 doses and 2 vaccination schedules. This blood stage candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
This study will collect blood samples for use in laboratory studies of malaria. The World Health Organization reports that 40 percent of the world's population is at risk for malaria, mostly in the poorest countries. It is a serious disease caused by parasites. Each year, 300-500 million infections lead to more than a million deaths. However, there are traits in red blood cells (erythrocyte) that protect people against malaria. In this study, polymorphism refers to the various kinds of red blood cell traits. The sickle cell trait is an example of one that seems to offer a natural survival advantage in children where malaria is common. Researchers at the Laboratory of Malaria and Vector Research are investigating ways in which the blood cell traits can offer such protection, and new knowledge gained can bring about medical advances. Of particular importance is studying how the malaria organism, Plasmodium, survives inside different red blood cells. A steady, consistent, and reliable supply of fresh whole blood is necessary for testing. Patients 18 to 65, weighing more than 110 lbs. and who do not have anemia or known HIV, Hepatitis C, or Hepatitis B may be eligible for this study. Patients will undergo a medical history and general assessment including vital signs of temperature, heart rate, and blood pressure. Blood will be collected from a vein in the arm, or rarely a vein in the hand. A complete blood count, or CBC, will be done to ensure that blood levels are sufficient and that blood donation is safe for a patient to do. Patients need to have enough hemoglobin, the part of red blood cells that transports oxygen throughout the body. The blood will also be tested to confirm the type of red blood cell traits of patients. About 1 to 8 tablespoons may be collected, but most blood samples will be small, that is, 1 to 4 teaspoons. After the patients' first visit, sessions will take 5-20 minutes. Blood collection will total no more than 2 cups from a donor during any 6-week period. Although the frequency of blood donations is not known at this time, it is unlikely that a patient will be asked to donate blood more than four times a year. It may be important for patients to undergo a repeat CBC or tests for blood chemistry if results are needed for research. Risks associated with blood collection are considered minimal. They include discomfort, occasional bruising or bleeding at the puncture site, and faintness. In this study, it is possible that a small amount of blood may be stored for future research, to help the researchers to learn more about malaria. There are no plans for the results from the various research laboratory tests to be made available to patients or to their private doctors. However, patients in this study may discuss the results of routine medical tests with the study investigators. Some of the blood collected will be tested for genetic conditions. Through genetic testing, researchers can learn more about how health or illness may be passed on to people by their parents, or from people to their children. All results of tests will remain confidential. Blood samples will be labeled by code, and reference to patients' identities will be protected. Participants will receive $50 for each blood donation. This study will not have a direct benefit for participants. Future research that uses their blood samples will help researchers to learn about malaria as well as how to prevent or treat the disease.
Malaria in pregnancy is one of the most important preventable causes of low birthweight worlwide and a major cause of severe maternal anaemia contributing to maternal mortality. Intermittent Preventive Treatment (IPT) with sulfadoxine-pyrimethamine (SP) is the currently adopted government recommendation for malaria control during pregnancy in Benin, but the emergence and the spread of resistance to SP justifies the evaluation of alternative anti-malarial drugs. Mefloquine (MQ), which has been proven effective and reasonably safe in this indication, may be an interesting alternative to SP. The aim of this trial is to compare the efficacy and safety of sulfadoxine-pyrimethamine and mefloquine for IPT. It is an equivalent study designed to test the hypothesis that MQ is as efficacious as SP to prevent malaria in pregnancy, and that it could replace SP when resistance of Plasmodium falciparum becomes too elevated. Primary endpoint will be the proportion of infants with low birthweight. Secondary endpoints will be the proportion of mothers with placental plasmodial infection, and the proportion of mothers with anaemia at delivery.
Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.
Health promotion in schools aims to improve the health and well being of students by empowering them with the knowledge, skills and confidence to take responsibility for their own health. We incorporated a malaria component to an established peer health education programme in schools in The Gambia, and evaluated its impact on knowledge attitudes and practice (KAP) of school students and their families using a cluster randomized design. Since malaria is a particular problem among children under 5 and pregnant women, students were encouraged to explain what they learned to their families, and we sought to evaluate whether the malaria messages were taken up by the students' families. Evaluation endpoints are KAP in students, and KAP in women living in the school students' home compound.
The purpose of this study is to find out whether taking certain anti-HIV medicines with certain antimalarial medicines affects the amount of the medicines in the blood. The study medicines that will be used are artemether/lumefantrine (antimalarial medication) and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not approved by the United States Food and Drug Administration (FDA) but is recommended as standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn about whether or not the use of these medicines together results in a change in blood levels of any of these medicines. The information obtained from this study will help doctors to provide a better treatment to children and adults with malaria and HIV.
Design: Single-centre Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN). Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital outpatient department. Sample size: N=120 Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three days (first and second day: 10mg/kg, third day: 5mg/kg). Statistical procedures: The primary analysis parameter is the proportion of clinical failures on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without PCR correction), the rate of early clinical failures, the rate of late parasitological failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the overall group of study children and for rural (n=50) and urban (n=50) study children separately. Study duration and dates: The study will be implemented in September-December 2005.