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
1 other identifier
interventional
330
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 30, 2016
June 1, 2014
2.3 years
June 19, 2013
September 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with adequate response to treatment
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 Outcomes (6)
Proportion of patients classified as Early Treatment Failures
Day 63
The parasite clearance time
Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.
Fever clearance time
Assessed every 6 hours until Day 3, or 24 hours without fever
Frequency of adverse and serious adverse events
Day 63
Proportion of patients classified as Late Clinical Failures
Day 63
- +1 more secondary outcomes
Study Arms (2)
Chloroquine
ACTIVE COMPARATOR25mg base/kg for 3 days
Dihydroartemisinin/Piperaquine
ACTIVE COMPARATORDihydroartemisinin 40 mg + piperaquine phosphate 320 mg per tablet; once daily for three days, doses depend on weight
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bu Gia Map Health Station
Phước Hòa, Binh Phuoc, Vietnam
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2013
First Posted
June 27, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 30, 2016
Record last verified: 2014-06