Vivax Malaria Clinical Trial
Official title:
A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (>10kg).
With the emergence of species of multi drug resistant P.falciparum across the archipelago
the Indonesian Centre for Disease Control (CDC) now recommends amodiaquine plus artesunate
in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of P.
falciparum. High levels of chloroquine resistance to P.vivax has also emerged in the eastern
provinces.
This trial sets out to assess two fixed dose artemisinin combination regimens: artekin
(DHA-Piperaquine) and coartemether (artemether-lumefantrine) against both P.falciparum and
P. vivax and their safety profiles.
Patients who present to an established rural outpatient clinic in Timika, Papua with
symptoms of acute, uncomplicated infection with P. falciparum, P.vivax or both species, will
after laboratory confirmation of the diagnosis and having given informed consent to
participate in the trial, be enrolled in the study. Drug administration will be supervised
once per day. Patients will be treated as out-patients and then seen daily for the first
week until aparasitaemic and thereafter at weekly visits to the clinic.
The data used from this trial will be used to make a public health decision to determine a
suitable alternative first line antimalarial in the Timika region. In order to ensure that
the data gathered will be relevant to the clinical setting in which the drugs will be used,
drug administration of medication will be deliberately designed to mimic conditions that
will be experienced with widespread deployment (eg once daily supervision).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 | |
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 |
NCT01288820 -
Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria
|
Phase 3 | |
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 |