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

A Randomised Controlled Trial to Assess the Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Binh Phuoc
      • Bu Gia Map, Binh Phuoc, Vietnam
        • Bu Gia Map Health Station

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 3 years;
  • Mono-infection with P. vivax, parasitemia > 250/µl asexual forms for in vivo and >8000 asexual parasites/µl blood for in vitro testing;
  • Presence of axillary or tympanic temperature ≥ 37.5 °C or history of fever during the past 24 h;
  • Ability to swallow oral medication;
  • Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
  • Informed consent/assent

Exclusion Criteria:

  • Presence of general danger signs or severe malaria according to the definitions of WHO (2000);
  • Mixed infection with P.falciparum and P.vivax of other plasmodium species;
  • Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
  • Regular medication, which may interfere with antimalarial pharmacokinetics;
  • Received antimalarial drugs in the previous 48 hours;
  • History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
  • Splenectomy;
  • First trimester of pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chloroquine
25mg base/kg for 3 days
Active Comparator: Dihydroartemisinin/Piperaquine
Dihydroartemisinin 40 mg + piperaquine phosphate 320 mg per tablet; once daily for three days, doses depend on weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with adequate response to treatment
Time Frame: Day 63
Adequate response = adequate clinical and parasitological response. Absence of parasitaemia on day 63, irrespective of temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
Day 63

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients classified as Early Treatment Failures
Time Frame: Day 63

One or more of the following:

  • danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia;
  • parasitaemia on day 2 higher than on day 0, irrespective of temperature;
  • parasitaemia on day 3 with temperature ≥ 37.5 ºC;
  • parasitaemia on day 3 ≥ 25% of count on day 0.
Day 63
The parasite clearance time
Time Frame: Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.
Defined as the time in hours from the first treatment dose to the first of two consecutive parasitemia counts of zero.
Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.
Fever clearance time
Time Frame: Assessed every 6 hours until Day 3, or 24 hours without fever
Defined as the time in hours from the first treatment dose to the start of the first sustained period of 24 hours without fever
Assessed every 6 hours until Day 3, or 24 hours without fever
Frequency of adverse and serious adverse events
Time Frame: Day 63
Day 63
Proportion of patients classified as Late Clinical Failures
Time Frame: Day 63

One or more of the following:

  • danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 63 in patients who did not previously meet any of the criteria of early treatment failure;
  • presence of parasitaemia on any day between day 4 and day 63 with temperature ≥ 37.5 ºC (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure
Day 63
Proportion of patients classified as Late Parasitological Failures
Time Frame: Day 63
Presence of parasitaemia on any day between day 7 and day 63 with temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure
Day 63

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

June 1, 2014

More Information

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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