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This is a continuous cohort study consisting of 200 participants (one third 6 months old to 5 years, one third 6 to 15 years old, one third ≥ 15 years old) i.e. a new patient will be recruited (from the same age group) for any patient who develops a Pv infection so that the cohort will always have 200 patients for 3 years. Each patient will be actively followed-up every 8 weeks until Plasmodium vivax infection occurs but the duration of follow up and the number of follow up visits for each patient will vary depending on when or if a vivax infection occurs and when the patient is recruited. Therefore, the minimum follow up period for each patient will be 6 months or time to vivax infection and the maximum will be 3 years if a patient does not get vivax infection and is recruited at the beginning of the study.
This study will evaluate the most likely approach to malaria elimination; the administration of a radical curative dose of primaquine to the entire potentially infected population. In this study we will focus on patients who have had vivax malaria in the past year and so are very likely to harbour liver hypnozoites. Radical treatment is not given on the Thai-Burmese border because risks are considered to outweigh benefits, but it is recommended in Thailand. We believe that this policy could be changed if there was sufficient information.
Patients who have received chloroquine only treatment could be considered as incompletely treated. We plan to conduct a carefully documented evaluation of radical treatment in such patients. Through this we aim to determine the incidence of vivax malaria in patients living in a vivax endemic area following radical treatment. This will provide information on the safety and tolerability of primaquine, used in the context most likely during an elimination programme, and also will provide information on the incidence of vivax malaria. Adults and children > 6 months old with a documented P.vivax infection in the last 12 months will be recruited. In conjunction with a parallel study evaluating epidemiology in treated vivax malaria, we will be able to characterize the relapse history of P vivax. This will provide the foundation for further studies evaluating the efficacy of primaquine regimens.
Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Shoklo Malaria Research Unit
University of Oxford
Published on BioPortfolio: 2014-07-23T21:09:58-0400
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A protozoan parasite that causes vivax malaria (MALARIA, VIVAX). This species is found almost everywhere malaria is endemic and is the only one that has a range extending into the temperate regions.
Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.
A protozoan parasite that occurs naturally in the macaque. It is similar to PLASMODIUM VIVAX and produces a type of malaria similar to vivax malaria (MALARIA, VIVAX). This species has been found to give rise to both natural and experimental human infections.
An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404)
A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia.
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