A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Oxford
Collaborators:
Ministry of public Health Afghanistan Wellcome Trust