A Phase 3 interventional study of Dihydroartemisinin + Piperaquine (Artekin) and artesunate-sulphadoxin/pyrimethamine, chloroquine in Uncomplicated Falciparum Malaria and Vivax Malaria, sponsored by University of Oxford. Completed at 4 sites in Afghanistan. Open to participants aged 3 Months and older. Per ClinicalTrials.gov, last updated 2018-05-09.
Sponsored by University of Oxford · Phase 3, Interventional, and Treatment
Malaria is a major public health problem in many provinces of Afghanistan the failure rate of chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to more than 60% overall and as high as 90% in Jalalabad. CQ remains fully effective against P vivax, and sulphadoxine-pyrimethamine (SP) remains effective against P falciparum (10-15% of cases fail to cure). The current malaria treatment protocol still continuing CQ for P.vivax and adopted Artmisinine based combination therapy (ACT) for treating (Pf) malaria, as most than 50% malaria has being diagnosed clinically, so due to this and other operational reasons the protocol needs to be simplified.
By comparing 56 day PCR corrected cure rate of DHA-PPQ with the standard treatment regimen as primary objective and comparing the safety, gametocytecidal effect and parasite clearance time as secondary objectives, our study titled: Randomized, Open Label, controlled, non-inferiority clinical trial for comparison of Efficacy \& safety, will provide scientific evidence to lead the simplification and improvement of the standard malaria treatment regimen in Afghanistan; to adopt a policy of treating both vivax and falciparum malaria with the same drug regimen.
With a significance level (α) = 0.05 and a power=80%, the calculated sample size is 274 per study arm. Therefore about1100 patients (274 per study-arm: 548 patients with falciaprum malaria and 548 patients with vivax malaria) will be recruited in Malaria reference Centers (MRCs) of three malaria endemic provinces (Nangarhar in the east, Thakhar in the north-east and Faryab in the north-west of country) after signing written inform consent form, according the inclusion and exclusion criteria and will be treated as out patients by giving the randomized drug dose under observation of study team and followed-up daily for 3 days (as treatment course of either arm is once daily dose for three days) and after than weekly up to day 56. and the study is planed to conducted in 3 provinces of Afghanistan for approximately 2 years.
Patients will be assessed clinically as well necessary laboratory tests will be performed and all the bio-medical findings will be recorded in special patient case record form, the electronic form of which will be broth to Trop. Med of Mahidol University for final analysis. The patients will be receiving the reasonable transportation cost for follow-up visits as well as one bed-net at the end of enrollment.
123 studies on the registry are indexed under Malaria, Vivax; 19 are open to participants now.
This study's enrollment of 1,086 is above the median of 150 across 103 interventional studies indexed under Malaria, Vivax.
Browse Malaria, Vivax studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Dihydroartemisinin+ Paperaquine (DHA+PPQ, Artekin)
Drug: Dihydroartemisinin + Piperaquine (Artekin)
The standard treatment for uncomplicated falciparum and vivax malaria are as follows: Uncomplicated falciparum: artesunate-sulphadoxin/pyrimethamine Vivax malaria: chloroquine
Drug: artesunate-sulphadoxin/pyrimethamine, chloroquine
Drug pages: Artenimol · Piperaquine
An adult dose consists of four doses of two tablets, given at 0, 8, 24 and 48 h. The approximate total adult dose is 6/48 mg/kg (DHA/PPQ). For children, a dose of 1.6/12.8 mg/kg is given at the same time intervals; this dosage will be obtained by dissolving the tablets in 5 ml of water.
Also known as: Artekin
The standard treatment will be in accordance with that in Afghanistan
PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR)
Time frame: Day 56
Crude or PCR uncorrected ACPR
Time frame: Day 56
Early treatment failure (failure to clear parasitaemia)
Time frame: 7 days
fever clearance times
Time frame: Days
parasite clearance times with no recrudescence over the observation period
Time frame: days
gametocyte clearance times
Time frame: weeks
Haemoglobin levels on day 14 compared to admission
Time frame: day 14
safety and tolerability (rate and severity of adverse events)
Time frame: day 56
Ran from Jul 2007 to primary completion in Feb 2010, 31 months.
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Artenimol · Piperaquine