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NCT ID: NCT00471666 Completed - Malaria Clinical Trials

Medical Implications of Coinfection With Malaria and Filariasis Parasites

Start date: May 7, 2007
Phase: N/A
Study type: Observational

This study will examine the clinical, immunological and epidemiological effects of concurrent infections with P. falciparum and W. bancrofti or M. perstans (the parasites that cause malaria and filariasis) on the frequency and severity of malaria infection in children and young adults in Mali, Africa. Residents of Tien gu bougou and Bougoudiana, Mali, who are between 1 and 20 years of age may be eligible for this study. Participants with and without filarial infection will be enrolled. Participants undergo the following tests and procedures: - Baseline evaluation with medical history and physical examination, blood tests and stool culture - Brief physical examinations weekly - Blood tests monthly for malaria - Standard treatment offered for anyone with malaria - Blood tests for filarial infection at the beginning, midpoint and end of the transmission season - Treatment for lymphatic filariasis is available through the National Program for the Elimination of Lymphatic Filariasis. There is no effective standard therapy for M. perstans. - Treatment for other parasitic worm infections, if needed.

NCT ID: NCT00471302 Completed - Malaria Clinical Trials

Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali

Start date: August 1, 2007
Phase:
Study type: Observational

This study will determine the immune response to malaria infection in healthy volunteers compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very serious in children. Developing an effective vaccine against the parasite that causes malaria is a crucial step toward controlling the disease; however, vaccines tested so far have provided very short-lived protection. A better understanding of the natural immunity to malaria may provide insight that can be applied to developing a more effective vaccine. People 18 years of age or older who live in Kambila, Tieneguebougou or Kalifabougou, Mali, and are in good health may be eligible for this study. Participants undergo a complete physical examination at the start of the study and then once a year for the 4-year duration of the study. They have a maximum of nine clinic visits a year to collect blood samples for research. The visits last about one hour, including a 30-minute observation time after the blood draw.

NCT ID: NCT00460525 Completed - Clinical trials for Plasmodium Falciparum Malaria

Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali

Start date: May 2007
Phase: Phase 2
Study type: Interventional

Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of children who get malaria after receiving a vaccine for rabies (an approved vaccine that does not prevent malaria). The children will be assigned to one of the vaccine groups by chance. Participants and doctors will not know which vaccine was given. Study participants will include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3 vaccine doses, by injection, to their upper arm. Study procedures will include physical exams and several blood samples. Participants will be involved in the study for 26 months.

NCT ID: NCT00452907 Completed - Malaria Clinical Trials

ACT MALI: Treatment of Malaria Based on Combination Therapies

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

Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia

NCT ID: NCT00431808 Recruiting - Malaria Clinical Trials

Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])

Start date: May 2007
Phase: Phase 1
Study type: Interventional

This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations. The phase Ib study will include adults who will be randomly allocated to either receive the malaria vaccine or the vaccine against Tetanus. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be follow-up up for immediate reactions to vaccination, and also over a longer term of one year. Blood will be taken to evaluate the biological safety parameters and also immune responses.

NCT ID: NCT00422084 Completed - Malaria Clinical Trials

Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.

NCT ID: NCT00414336 Completed - Malaria Clinical Trials

Phase I Study of Safety and Immunogenicity of AMA1-C1Alhydrogel + CPG 7909 Vaccine for Malaria

Start date: December 15, 2006
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety of an experimental vaccine can protect people from malaria and study its effects. Malaria, which affects many people in Mali and other countries in Africa, is caused by germs spread by mosquito bites. In Mali, the disease is the leading cause of death. Researchers at the Malaria Research and Training Center at the University of Bamako are working with NIH to develop an experimental vaccine against the disease. The vaccine, called AMA1-C1Alhydrogel (or AMA1-C1), contains a small part of the malaria-causing germ. CPG-7909 is a product to improve the body's reactions to vaccines. Patients ages 18 to 45 who are in good health, who live in Don gu bougou, Mali, and plan to stay there for the study duration, and who are not pregnant or breast feeding may be eligible for this study. There will be 24 participants. At an initial evaluation of 2 to 3 hours, patients will have a physical examination and undergo blood and urine tests regarding the blood, kidneys, and liver. During the study, patients will receive two injections of one of the two experimental malaria vaccines. Injections of the same vaccine each time, 4 weeks apart, are given in an arm muscle. Patients will receive either AMA1-C1 or AMA1-C1 with CPG-7909 but will not know which of the vaccines they receive until the study's end. After each injection, patients will stay in the clinic for 30 minutes for observation. They will return after 1, 2, 3, 7, and 14 days to be examined and report how they are feeling. Blood and urine samples will be collected at some visits. Each clinic visit takes 1 to 2 hours. If for some reason a patient receives only one injection, he or she will be asked to return to the clinic for routine visits until the study's end. After the first 2 months, patients will return to the clinic once a month for 30 weeks. In that period, 12 blood samples will be taken. Researchers want to be sure that the vaccine is not harmful as well as to measure the vaccine's effects. Risks in this study include pain, swelling, and redness at the injection site; fever; and gastrointestinal problems. Some people have had a temporary decrease in white blood cells after receiving the vaccine. There is a small chance of a severe allergic reaction. However, researchers will closely watch patients immediately after each injection and will give treatment if a serious reaction occurs. Participants will receive 75 kilos of rice and 75 kilos of millet (165 lb. of ...

NCT ID: NCT00386763 Completed - Malaria Clinical Trials

Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

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

This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

NCT ID: NCT00384267 Completed - Malaria Clinical Trials

Congenital and Neonatal Malaria in Mali

Start date: October 2006
Phase: N/A
Study type: Observational

This study will look at blood samples taken from 300 preterm babies and newborns admitted for inpatient care at Hopital Gabriel Toure in Bamako, Mali, and to gather information that will help the investigators verify the role of malaria in illness of very small babies. Blood samples will be taken from the mothers so that the investigators can find out if they have a malaria infection and how their body fights malaria. The investigators will also determine whether the mother and newborn baby are infected with the same malaria parasite. The information from this study may be used to improve malaria treatment in very small babies. Mothers and babies whose blood is tested will receive treatment for malaria as recommended by the National Malaria Control Program (NCMP).

NCT ID: NCT00371735 Completed - Malaria, Falciparum Clinical Trials

Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria

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

CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria. The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug. The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.