Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01288820
Study type Interventional
Source University of Oxford
Contact
Status Completed
Phase Phase 3
Start date January 2011
Completion date April 2012

See also
  Status Clinical Trial Phase
Completed NCT01625871 - Artemether/Lumefantrine and Vivax Malaria Phase 3
Completed NCT02876549 - G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria Phase 4
Completed NCT01218932 - Pharmacokinetic Study of Primaquine and Chloroquine in Healthy Subjects Phase 1
Recruiting NCT04228315 - Biomarkers of P. Vivax Relapse N/A
Completed NCT02118090 - Assessment of Plasmodium Vivax Chloroquine Resistance in Cambodia: Phase 4
Completed NCT01074905 - Study on the Treatment of Vivax Malaria Phase 3
Completed NCT04222088 - TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
Completed NCT01546961 - Chloroquine Population Pharmacokinetics in Pre and Post-partum Women N/A
Completed NCT00158548 - ACT With Chloroquine, Amodiaquine & Sulphadoxine-pyrimethamine in Pakistan Phase 3
Completed NCT00682578 - A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan Phase 3
Completed NCT00157833 - A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia. N/A
Active, not recruiting NCT03529396 - Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients Phase 2
Recruiting NCT05874271 - Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea N/A
Completed NCT05958797 - TES of Chloroquine for Pv in the Philippines in 2016
Completed NCT01716260 - Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan N/A
Completed NCT01640574 - Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD) Phase 3
Completed NCT01076868 - Incidence of Vivax Along the Thai Burma Border N/A
Completed NCT00158561 - Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria Phase 3
Completed NCT01780753 - Primaquine Pharmacokinetics in Lactating Women and Their Infants Phase 1
Completed NCT06044805 - Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Phase 4