Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam
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| ClinicalTrials.gov Identifier: NCT01887821 |
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Recruitment Status :
Completed
First Posted : June 27, 2013
Last Update Posted : September 30, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plasmodium Vivax Malaria | Drug: Chloroquine Drug: Dihydroartemisinin/Piperaquine | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 330 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomised Controlled Trial to Assess the Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam |
| Study Start Date : | February 2013 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Chloroquine
25mg base/kg for 3 days
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Drug: Chloroquine |
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Active Comparator: Dihydroartemisinin/Piperaquine
Dihydroartemisinin 40 mg + piperaquine phosphate 320 mg per tablet; once daily for three days, doses depend on weight
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Drug: Dihydroartemisinin/Piperaquine |
- 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.
- 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.
- 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.
- 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
- Frequency of adverse and serious adverse events [ Time Frame: 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
- 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
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| Ages Eligible for Study: | 3 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887821
| Vietnam | |
| Bu Gia Map Health Station | |
| Bu Gia Map, Binh Phuoc, Vietnam | |
| Responsible Party: | Oxford University Clinical Research Unit, Vietnam |
| ClinicalTrials.gov Identifier: | NCT01887821 |
| Other Study ID Numbers: |
07MA |
| First Posted: | June 27, 2013 Key Record Dates |
| Last Update Posted: | September 30, 2016 |
| Last Verified: | June 2014 |
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Malaria Malaria, Vivax Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Chloroquine Piperaquine |
Artenimol Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Antirheumatic Agents |