Status:
COMPLETED
A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Wellcome Trust
Ministry of public Health Afghanistan
Conditions:
Uncomplicated Falciparum Malaria
Vivax Malaria
Eligibility:
All Genders
3+ years
Phase:
PHASE3
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%...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1086 Patients enrolled
Trial Details
Trial ID
NCT00682578
Start Date
July 1 2007
End Date
February 1 2010
Last Update
May 9 2018
Active Locations (4)
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1
Provincial Malaria Control Centers (MRC)
Faryab, Afghanistan
2
Provincial Malaria Control Centers (MRC)
Jalalabad, Afghanistan
3
Provincial Malaria Control Centers (MRC)
Maymana, Afghanistan
4
Provincial Malaria Control Centers (MRC)
Takhar, Afghanistan