Status:
UNKNOWN
Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
University for Development Studies, Tamale, Ghana
Kintampo Health Research Centre, Ghana
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated mala...
Detailed Description
Malaria remains a major cause of morbidity and mortality among children in sub-Saharan Africa. Current malaria control largely consists of rapid treatment of patients. Amodiaquine-artesunate and other...
Eligibility Criteria
Inclusion
- Male and female outpatients aged 6 to 59 months
- Body weight \>5 kg
- Uncomplicated Plasmodium falciparum malaria
- Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl
- Axillary temperature ≥37.5°C
- Ability to tolerate oral therapy
- Informed consent by the legal representative of the subject
- Residence in study area
Exclusion
- Previous participation in this clinical trial
- Haemoglobin \<5 mg/dl
- Mixed plasmodial infection
- Danger signs (unable to drink; repeated vomiting; recent history of convulsions;lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO.
- Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
- Concomitant disease masking assessment of response
- History of allergy or intolerance against study medications
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00238017
Start Date
October 1 2005
End Date
December 1 2005
Last Update
February 2 2006
Active Locations (1)
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1
University for Development Studies
Tamale, Northern Region, Ghana