A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan
Randomized Clinical Trial of the Efficacy and Safety of Dihydroartimisinine+Papiraquine (Artekin) Compared With First Line Drugs for Treatment of Vivax and Uncomplicated Falciparum Malaria in Afghanistan
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Faryab, Afghanistan
- Provincial Malaria Control Centers (MRC)
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Jalalabad, Afghanistan
- Provincial Malaria Control Centers (MRC)
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Maimana, Afghanistan
- Provincial Malaria Control Centers (MRC)
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Takhar, Afghanistan
- Provincial Malaria Control Centers (MRC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Uncomplicated falciparum or vivax malaria or mixed species infection, as confirmed in a peripheral blood slide.
- No signs of severe malaria
- Age over three months.
- Non-pregnant, (test for β-HCG in women of child-bearing age).
- Weight ≥5 kg
- Willingness to participate and written informed consent provided by the patient or in case of children by attending guardians/parents.
- Not enrolled in any other investigational drug study in the previous month
Exclusion Criteria:
- Clinical or laboratory features suggesting severe malaria.
- Known cardiac, renal, hepatic or other severe disease, or requirement for hospital treatment
- Recurrent vomiting.
- Not eligible for follow-up.
- Lactating mother
- Hyperparasitemia of P. falciparum > 100,000/µL
- Treatment with Artesunate or Chloroquine in the past one month, Fansidar in the past one and the half months and Artekin in past 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Artekin
Dihydroartemisinin+ Paperaquine (DHA+PPQ, Artekin)
|
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.
Other Names:
|
|
ACTIVE_COMPARATOR: Standard treatment
The standard treatment for uncomplicated falciparum and vivax malaria are as follows: Uncomplicated falciparum: artesunate-sulphadoxin/pyrimethamine Vivax malaria: chloroquine |
The standard treatment will be in accordance with that in Afghanistan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR)
Time Frame: Day 56
|
Day 56
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Crude or PCR uncorrected ACPR
Time Frame: Day 56
|
Day 56
|
|
Early treatment failure (failure to clear parasitaemia)
Time Frame: 7 days
|
7 days
|
|
fever clearance times
Time Frame: Days
|
Days
|
|
parasite clearance times with no recrudescence over the observation period
Time Frame: days
|
days
|
|
gametocyte clearance times
Time Frame: weeks
|
weeks
|
|
Haemoglobin levels on day 14 compared to admission
Time Frame: day 14
|
day 14
|
|
safety and tolerability (rate and severity of adverse events)
Time Frame: day 56
|
day 56
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ghulam R Awab, MD, Provincial Malaria Control Centers (MRC)
Publications and helpful links
General Publications
- Awab GR, Imwong M, Pukrittayakamee S, Alim F, Hanpithakpong W, Tarning J, Dondorp AM, Day NP, White NJ, Woodrow CJ. Clinical trials of artesunate plus sulfadoxine-pyrimethamine for Plasmodium falciparum malaria in Afghanistan: maintained efficacy a decade after introduction. Malar J. 2016 Feb 25;15:121. doi: 10.1186/s12936-016-1167-z.
- Awab GR, Pukrittayakamee S, Imwong M, Dondorp AM, Woodrow CJ, Lee SJ, Day NP, Singhasivanon P, White NJ, Kaker F. Dihydroartemisinin-piperaquine versus chloroquine to treat vivax malaria in Afghanistan: an open randomized, non-inferiority, trial. Malar J. 2010 Apr 21;9:105. doi: 10.1186/1475-2875-9-105.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malaria, Falciparum
- Malaria, Vivax
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Anthelmintics
- Folic Acid Antagonists
- Schistosomicides
- Antiplatyhelmintic Agents
- Chloroquine
- Pyrimethamine
- Artesunate
- Piperaquine
- Artenimol
Other Study ID Numbers
- BKMAL0701
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