Incidence of Vivax Along the Thai Burma Border (VHC)
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|ClinicalTrials.gov Identifier: NCT01076868|
Recruitment Status : Unknown
Verified August 2013 by University of Oxford.
Recruitment status was: Recruiting
First Posted : February 26, 2010
Last Update Posted : August 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Vivax Malaria||Drug: Primaquine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining the Incidence of New Plasmodium Vivax Infections After Radical Treatment Following Vivax Malaria Along the Thai Burma Border|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2014|
Primaquine 14 days
Primaquine x 14 days
Other Name: primaquine 0.5 mg/kg/day
- Incidence [ Time Frame: Up to 3 years ]Incidence of primary infections with vivax malaria
- Adverse events [ Time Frame: Up to 3 years ]Adverse event profile of primaquine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076868
|Contact: Phaik Yeong Cheah, PhDfirstname.lastname@example.org|
|Shoklo Malaria Research Unit||Recruiting|
|Mae Sot, Tak, Thailand|
|Contact: Cindy Chu, MD email@example.com|
|Principal Investigator: Francois Nosten, MD|
|Principal Investigator:||Francois Nosten, MD||Shoklo Malaria Research Unit|