Status:
COMPLETED
Trial of Artesunate Combination Therapy in Pakistan
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
HealthNet TPO
Conditions:
Uncomplicated Falciparum Malaria
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief Summary
This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan. A placebo controlled trial was carried out to assess two potentia...
Detailed Description
A randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicat...
Eligibility Criteria
Inclusion
- presentation at basic health unit with suspected clinical malaria
- mono-infection infection with P. falciparum confirmed by microscopy
- over 2 years of age (no upper age restriction)
- weight over 5 kg (no upper weight restriction)
- if of child bearing age then non-pregnant and willing to remain so for the duration of the study
- greater than 1 asexual parasite per 10 fields
- understands and is willing to sign the consent form
- a resident in the study site willing to collaborate for a full period of follow-up
- no signs of severe malaria
Exclusion
- other serious disease (e.g., cardiac, renal or hepatic)
- in women of child bearing age, pregnancy
- allergy to any of the study drugs or related compounds
- reports to have used any malaria drugs in the last 21 days
- other species of malaria seen
- signs of severe malaria
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT00959517
Start Date
July 1 2001
End Date
August 1 2006
Last Update
August 14 2009
Active Locations (1)
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1
HealthNet International
Peshawar, Pakistan