Vivax Malaria Clinical Trial
— CRePViCamOfficial title:
Assessing Chloroquine Resistance of Plasmodium Vivax in Malaria Endemic Area
Verified date | March 2015 |
Source | Institut Pasteur, Cambodia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Cambodia: Ministry of Health |
Study type | Interventional |
The investigators propose to leverage the unique infrastructures and expertise of National Centre for Parasitology Entomology and Malaria Control and the Pasteur Institute in Cambodia and combine modern fieldwork, including a mobile laboratory fully equipped for molecular biology and culture experiments, with state-of-the-art genomic analyses to investigate how Plasmodium vivax parasites respond to antimalarial drugs. The investigators will focus on resistance to CQ, the choice treatment for vivax malaria in most endemic countries, for which treatment failures have been reported in Cambodia. The study will address some of the key biological mechanisms limiting the efficiency of drug therapy in P. vivax, including the identification of genetic polymorphisms underlying drug resistance in Cambodian P. vivax. The findings will provide a first unbiased perspective on the mechanisms of drug resistance in P. vivax and have the strong potential to significantly improve malaria control in Southeast Asia.
Status | Completed |
Enrollment | 73 |
Est. completion date | March 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: (i) Being aged 15 years or more with competency to give informed consent, (ii) Being positive for P. vivax and mono-infected Exclusion Criteria: (i) Being aged 14 years or less (ii) Individuals with illness that affected competency to give informed consent, (iii) Pregnant or lactating women (iv) Having taken antimalarial drugs in the past month |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Cambodia | Provincial Hospital | Ban Lung | Rattanakiri |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur, Cambodia | National Institute of Allergy and Infectious Diseases (NIAID) |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with P. vivax CQ resistant parasite | Based on parasite clearance time (slow versus fast clearers) and treatments failure (according to the CQ blood concentration) | 6 months | No |
Secondary | Number of isolates characterized by whole genome sequencing and multiple Single Nucleotide Polymorphisms Bar Code | P. vivax Isolates will be characterize by SNPs barcode and whole genome sequencing. The final objective is to defined correlations between SNPs detected by whole genome sequencing or bar coding and in vivo and in vitro phenotype | 1 year | No |
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