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A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00682578
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : May 9, 2018
Wellcome Trust
Ministry of public Health Afghanistan
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment Phase
Uncomplicated Falciparum Malaria Vivax Malaria Drug: Dihydroartemisinin + Piperaquine (Artekin) Drug: artesunate-sulphadoxin/pyrimethamine, chloroquine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1086 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Artekin
Dihydroartemisinin+ Paperaquine (DHA+PPQ, Artekin)
Drug: Dihydroartemisinin + Piperaquine (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 Name: Artekin

Active Comparator: Standard treatment

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
The standard treatment will be in accordance with that in Afghanistan

Primary Outcome Measures :
  1. PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR) [ Time Frame: Day 56 ]

Secondary Outcome Measures :
  1. Crude or PCR uncorrected ACPR [ Time Frame: Day 56 ]
  2. Early treatment failure (failure to clear parasitaemia) [ Time Frame: 7 days ]
  3. fever clearance times [ Time Frame: Days ]
  4. parasite clearance times with no recrudescence over the observation period [ Time Frame: days ]
  5. gametocyte clearance times [ Time Frame: weeks ]
  6. Haemoglobin levels on day 14 compared to admission [ Time Frame: day 14 ]
  7. safety and tolerability (rate and severity of adverse events) [ Time Frame: day 56 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00682578

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Provincial Malaria Control Centers (MRC)
Faryab, Afghanistan
Provincial Malaria Control Centers (MRC)
Jalalabad, Afghanistan
Provincial Malaria Control Centers (MRC)
Maimana, Afghanistan
Provincial Malaria Control Centers (MRC)
Takhar, Afghanistan
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Ministry of public Health Afghanistan
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Principal Investigator: Ghulam R Awab, MD Provincial Malaria Control Centers (MRC)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Oxford Identifier: NCT00682578     History of Changes
Other Study ID Numbers: BKMAL0701
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Keywords provided by University of Oxford:
falciparum malaria
vivax malaria
Additional relevant MeSH terms:
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Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents