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Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam

NCT01887821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2016-09-30

No results posted yet for this study

Summary

This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam.

Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other.

Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment.

The results of the study will be used to inform malaria treatment guidelines in Viet Nam.

Conditions

  • Plasmodium Vivax Malaria

Interventions

DRUG

Chloroquine

DRUG

Dihydroartemisinin/Piperaquine

Sponsors & Collaborators

  • Institute of Malaria, Parasitology and Entomology, Ho Chi Minh City, Viet Nam

    collaborator UNKNOWN

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Agency for Science, Technology and Research

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Vietnam

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 NCT01887821 on ClinicalTrials.gov