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Malaria clinical trials

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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 ...

NCT ID: NCT00111163 Completed - Anemia Clinical Trials

Intermittent Preventive Treatment With Antimalarials in Kenyan Infants

Start date: March 2004
Phase: N/A
Study type: Interventional

The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.

NCT ID: NCT00084227 Completed - Malaria, Falciparum Clinical Trials

Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America

Start date: July 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.

NCT ID: NCT00082576 Completed - Malaria, Falciparum Clinical Trials

Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa

Start date: June 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.

NCT ID: NCT00075049 Completed - Malaria Clinical Trials

Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria

Start date: December 2003
Phase: Phase 1/Phase 2
Study type: Interventional

This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.

NCT ID: NCT00074841 Completed - Clinical trials for PLASMODIUM FALCIPARUM MALARIA

Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India

Start date: September 2003
Phase: Phase 2/Phase 3
Study type: Interventional

This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India.