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Assessment of Plasmodium Vivax Chloroquine Resistance in Cambodia:

NCT02118090 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2015-03-24

No results posted yet for this study

Summary

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.

Conditions

  • Vivax Malaria

Interventions

DRUG

Chloroquine sulfate

Chloroquine sulfate (NIVAQUINE) - 30 mg/kg for 3 days

DRUG

DHA-PP

DHA-PIP (Duo-Cotecxin®, DHA 40 mg and PP 320 mg, Zhejiang Holley Nanhu Pharamaceutical Co. Ltd, Jiaxing, Zhejiang province, China): one tablet of DHA-PIP contains 40 mg of dihydroartemisinin (DHA) and 320 mg piperaquine (PIP). It is an oral administration, one dose a day for 3 consecutive days. An adult dose (≥40 kg to 60kg body weight or more than 15 years old) consisted of three doses of 3 tablets over consecutive days (Total dose 9 tablets). The approximate total adult dose was 2-4 mg/kg for DHA and 20mg/kg for PP.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Institut Pasteur, Cambodia

    lead OTHER

Principal Investigators

  • Dysoley Lek, MD · National Centre for Parasitology Entomology and Malaria Control

  • Didier Ménard, PharmD, PhD · Institut Pasteur in Cambodia

  • Jean Popovici, PhD · Institut Pasteur in Cambodia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Cambodia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02118090 on ClinicalTrials.gov