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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wellcome Trust
Ministry of public Health Afghanistan
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00682578
First received: May 14, 2008
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR) [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 1100
Study Start Date: July 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682578

Contacts
Contact: Arjen Dondrop, MD, PhD +6622036303 arjen@tropmedres.ac
Contact: Ghulam R Awab, MD +668519944246 awabgr@yahoo.com

Locations
Afghanistan
Provincial Malaria Control Centers (MRC) Recruiting
Farya, Afghanistan
Contact: Ghulam R Awab, MD         
Principal Investigator: Ghulam R Awab, MD         
Provincial Malaria Control Centers (MRC) Recruiting
Jalalabad, Afghanistan
Contact: Ghulam R Awab, MD         
Principal Investigator: Ghulam R Awab, MD         
Provincial Malaria Control Centers (MRC) Recruiting
Maimana, Afghanistan
Principal Investigator: Ghulam R Awab, MD         
Provincial Malaria Control Centers (MRC) Recruiting
Takhar, Afghanistan
Principal Investigator: Ghulam R Awab, MD         
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Ministry of public Health Afghanistan
Investigators
Principal Investigator: Sasithon Pukrittayakamee, MD Mahidol University
  More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ghulam Rahim Awab, Mahidol Oxford Research Unit
ClinicalTrials.gov Identifier: NCT00682578     History of Changes
Other Study ID Numbers: BKMAL0701
Study First Received: May 14, 2008
Last Updated: January 21, 2010
Health Authority: Afghanistan: Ministry of Public Health

Keywords provided by University of Oxford:
falciparum malaria
vivax malaria
dihydroartemisinin-piperaquine

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Artesunate
Chloroquine
Pyrimethamine
Piperaquine
Dihydroartemisinin
Artemisinins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014