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Malaria clinical trials

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NCT ID: NCT00120822 Completed - Malaria Clinical Trials

Folic Acid Supplementation in Gambian Primigravidae

Start date: July 2002
Phase: Phase 3
Study type: Interventional

Supplementation with folic acid and iron is recommended for pregnant women in order to prevent them from developing anemia. In malaria endemic areas of Africa, the World Health Organization (WHO) now recommends that pregnant women should also be given sulfadoxine-pyrimethamine (SP) once a month after quickening to protect them against malaria which is especially harmful during pregnancy. However, folic acid is an antagonist of SP so there is a possibility that giving folic acid with SP could interfere with the ability of the latter to provide protection against malaria. To investigate this possibility Gambian primigravidae with malaria parasitemia have been given SP and folic acid at the same time or on separate occasions two weeks apart and the ability of SP to cure the malaria infection investigated.

NCT ID: NCT00120809 Completed - Malaria Clinical Trials

Intermittent Preventative Treatment With Sulfadoxine-Pyrimethamine in Gambian Multigravidae

Start date: July 2002
Phase: Phase 3
Study type: Interventional

Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth weight which, in turn, increases infant mortality. Thus, the World Health Organization (WHO) now recommends that all pregnant women who live in malaria endemic areas of Africa should receive sulfadoxine-pyrimethamine (SP) at monthly intervals during the second and third trimesters of pregnancy. Malaria is especially severe during first pregnancies and the value of intermittent preventative treatment with SP during first pregnancies has been clearly shown. However, it is less certain whether multigravidae, who are at less risk, also benefit from intermittent preventative treatment with SP. To investigate this, a trial has been conducted in Gambian multigravidae who were given intermittent preventative treatment with SP or placebo during the second and third trimesters. The prevalence of anemia six weeks after delivery, low birth weight and poor outcome of pregnancy in women in each group were studied.

NCT ID: NCT00119145 Completed - Malaria Clinical Trials

Kintampo Trial of Combination Therapy for Malaria

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

Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies. Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen. This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial. The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.

NCT ID: NCT00119132 Completed - Malaria Clinical Trials

Effectiveness of Intermittent Preventive Treatment for Malaria in Children

Start date: June 2005
Phase: Phase 2/Phase 3
Study type: Interventional

Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.

NCT ID: NCT00118807 Completed - Malaria Clinical Trials

Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children

Start date: August 2003
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.

NCT ID: NCT00118794 Completed - Malaria Clinical Trials

Lapdap and Coartemether for Uncomplicated Malaria

Start date: September 2004
Phase: Phase 3
Study type: Interventional

Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.

NCT ID: NCT00118027 Completed - Pregnancy Clinical Trials

A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda

Start date: May 2003
Phase: N/A
Study type: Interventional

SUMMARY Background: Malaria is the leading cause of morbidity and mortality among pregnant women in Uganda. Although effective tools for prevention and control of malaria exist, their delivery presents a problem. Intermittent presumptive treatment (IPT) with sulfadoxine-pyrimethamine (SP) is effective, yet >60% of women in Uganda do not get it as < 40%, attend antenatal care. Effective ways of delivering IPT with SP to pregnant women at a community level need to be developed. This study assessed whether community based resource persons like traditional birth attendants (TBAs), community reproductive health workers (CRHWs), adolescent peer mobilizers (APMs) and drug-shop owners (DSV) can distribute IPT with SP to pregnant women. Objectives: The objectives of this study were: - To assess community based approaches for delivering malaria prevention to pregnant women in Uganda; - To assess community perceptions, beliefs and practices associated with malaria treatment and prevention in pregnancy; - To assess whether community based resource persons can deliver IPT to pregnant women and reach those most at risk; - To assess the impact of IPT on anaemia and pregnancy outcome; - To estimate cost-effectiveness of the approaches and assess the acceptability and sustainability of the approaches. Methods: The study was conducted in 5 sub-counties of the Mukono district, situated on the shores of L. Victoria in Central Uganda. The district is hyper-endemic for malaria. 25 parishes with a total population of 75,000 people were used to test the new approaches. Phase 1 obtained qualitative data on community perceptions, beliefs and practices associated with malaria prevention in pregnancy. Phase 2 was an intervention study that assessed distribution of IPT to pregnant women by TBAs, CRHWs, APMs and DSVs compared with health units. Pregnant women of all parities were enrolled. Key resource persons in each parish were identified to sensitise the communities on the intervention. Data was collected regarding: timing of the first dose of SP, proportion of women who complete two doses of SP, birth weight of babies, proportion of low birth-weight babies, and proportion of adolescent pregnancies. The third phase of the study evaluated the sustainability of the approaches. Work Plan: The first phase of the study took two months. The second phase took 14-16 months. Data analysis was expected to take 12 months.

NCT ID: NCT00116766 Completed - Malaria Clinical Trials

Field Evaluation of Plant-based Mosquito Control

Start date: July 2005
Phase: Phase 2
Study type: Interventional

Isolated minority communities in China use traditional plant-based methods of mosquito control. This study is evaluating 4 plants used in this way by monitoring mosquitoes entering houses on nights when the plants are being used in this way. A blind, placebo controlled study design will monitor plant use and record mosquito species / numbers caught in CDC light traps indoors over 3 months.

NCT ID: NCT00115921 Completed - Anemia Clinical Trials

Evaluation of Home-Based Management of Fever in Urban Ugandan Children

Start date: July 2005
Phase: N/A
Study type: Interventional

The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.

NCT ID: NCT00114010 Completed - Malaria Clinical Trials

Experimental Vaccine for Malaria

Start date: April 1, 2005
Phase: Phase 1
Study type: Interventional

This study will examine the safety and immune response of healthy adult volunteers to AMA1-C1, an experimental malaria vaccine developed by the NIAID. Malaria affects about 300 million to 500 million people worldwide each year, causing from 2 million to 3 million deaths. Increasing drug resistance to the malaria parasite, as well as widespread resistance of mosquitoes (the insects that transmit the parasite) to pesticides are reducing the ability to control malaria through these strategies. A vaccine that could reduce illness and death from malaria would be a valuable new resource in the fight against this disease. Early tests of AMA1-C1 in 66 people in the United States and in Mali, West Africa, found no serious side effects of the vaccine. This study will test a shorter schedule of vaccinations with AMA1-C1 than that used in the previous studies. Healthy volunteers between 18 and 50 years of age who weigh at least 110 pounds and with no travel to malaria endemic areas in the past 12 months may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and a urine pregnancy test for women who are able to bear children. Participants are randomly assigned to receive three injections of either the experimental malaria vaccine or a placebo (a solution that does not contain the vaccine) over a 2-month period. The shots are given in an upper arm muscle, each 1 month apart. On the day of each injection, participants give a history of symptoms since the last visit, have a brief physical examination and blood test and, for women, a blood or urine pregnancy test. After the injection, participants remain in the clinic 60 minutes for observation. In addition to the injections, participants undergo the following procedures: - Record temperature and symptoms on a diary card daily for the first 7 days after each injection. - Follow-up clinic visits 1, 3, 7 and 14 days after each shot to check for side effects. Blood samples are drawn before each injection and at each return clinic visit to check the safety and immune response to the vaccine. - Have apheresis, a special procedure that separates certain components of the blood, 7 days after each injection to measure the function of germ-fighting blood cells. For this procedure, blood is drawn through a needle in an arm vein and directed into a machine that separates the different types of blood cells. The white cells are collected in a plastic ...