Vivax Malaria Clinical Trial
Official title:
Comparison of the Efficacy and Safety of Two ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria in North Sumatera, Indonesia: 1 Year Followup
This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.
The emergence and spread of drug resistance are major problems in the control of malaria.
Resistance to chloroquine in P. vivax was first detected in 1989 then spread to other parts
of the world. In Indonesia, resistance of P. vivax to chloroquine has emerged in many parts
of the country, ranging from over 50% failure rates in Papua to 20% failure rates in Nias,
North Sumatera. Artemisinin derivatives are the most potent and rapidly acting antimalarial
drugs available nowadays and also seem to be effective for treatment of vivax malaria, but
the number of studies evaluating this is limited. If artemisinin combination therapies
(ACTs) are combined with drug that can eliminate parasites in the liver, such as primaquine,
this will further optimize the treatment of P. vivax infections. The addition of a course of
primaquine will provide radical cure from relapse, and importantly will reduce the
transmission of infection because of its gametocyticidal effects. Since 2008, Indonesian
government has deployed artesunate-amodiaquine (AS-AQ) as the first line treatment for
uncomplicated vivax malaria and promotes radical cure by adding primaquine (PQ). For more
than 50 years, Indonesia has used standard dose of primaquine (0.25mg/kg for 14 days)
sometimes without prior test of G6PD status of the patients because the screening test is
not usually available especially in remote areas. Unfortunately, there is no data to
evaluate the safety and efficacy of this standard dose.
Patients with fever or history of fever in preceding 48 hours who are attending the public
health centre in study area (study centre) will be examined. Thick and thin blood smear will
be taken, stained and examined under light microscope. Slides will be carefully read
(according the procedure) for P. vivax malaria. The patients will be assessed by the trial
doctor, if they meet all of the inclusion criteria and none of the exclusion criteria, they
will receive detail explanation on study & enrolment condition by trial staff. If they agree
to participate in the study, they will sign the informed consent form and will be randomized
to receive either AS-AQ plus PQ or DHP plus PQ. Essential laboratory tests (hemoglobin, and
methemoglobin) will be performed, and filter blood paper for G6PD genotyping will be
collected. No patients will be screened for G6PD status. Oral treatment dose will be given
under close observation, those who vomit within half an hour will be re-dosed; if they vomit
again they will be withdrawn. Patients will be managed as outpatient and be asked to return
to the clinic daily, on fourteen consecutive days, days 1-14) to receive physical
examination, laboratory test and study treatment and adverse events monitoring, and then
weekly on days 21, 28, 35, 42 or any day if feel unwell. Patients who missed their
appointments on scheduled day after day 3 will still be included in the study if they appear
on the next day (24 hours), or will be visited at home. Patients who develop any acute
hemolytic attack symptoms or reduction on hemoglobin during treatment will be closely
observed and transfer to hospital for blood transfusion if needed and withdrawn from the
study.
After days 42, patients will be visited at home every month (± 1 week from scheduled day
will still be accepted) for up to 1 year. Each patient will be given serial number and an
appointment card marked with the dates of follow-up.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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