Incidence of Vivax Along the Thai Burma Border (VHC)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Determining the Incidence of New Plasmodium Vivax Infections After Radical Treatment Following Vivax Malaria Along the Thai Burma Border|
- Incidence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Incidence of primary infections with vivax malaria
- Adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Adverse event profile of primaquine
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Primaquine 14 days
Primaquine x 14 days
Other Name: primaquine 0.5 mg/kg/day
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|