- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076868
Incidence of Vivax Along the Thai Burma Border (VHC)
Determining the Incidence of New Plasmodium Vivax Infections After Radical Treatment Following Vivax Malaria Along the Thai Burma Border
Study Overview
Detailed Description
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.
Conclusions: The incidence of new Pv infection after radical cure with primaquine is estimated to be 0.2 infections/person year and declined during the course of the study. Further results have not been analysed yet.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tak
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Mae Sot, Tak, Thailand
- Shoklo Malaria Research Unit
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Asymptomatic adults and children ≥ 6 months
- Documented P.vivax infection in the last 12 months who have not received radical treatment with primaquine
- Weight≥ 7 kg for children
- Participant (or parent/guardian if <18 years old) is willing and able to give written informed consent
- Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements
Exclusion Criteria:
- History of allergy to primaquine
- Medical conditions such as known chronic diseases (TB, HIV, cardio vascular diseases), allergies, mental illnesses and similar conditions that could make the interpretation of symptoms or the follow up difficult.
- Other conditions such as drug addiction, known poor compliance with treatment or follow up.
- Inability to tolerate oral medication
- Pregnancy
- G6PD deficiency
- Blood transfusion in the last 3 months
- Microscopic evidence of Plasmodium vivax, P.falciparum, P. malariae or ovale
- Fever ≥37.5C
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Primaquine
Primaquine 14 days
|
Primaquine x 14 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence
Time Frame: Up to 3 years
|
Incidence of primary infections with vivax malaria
|
Up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: Up to 3 years
|
Adverse event profile of primaquine
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMRU0909
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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