Status:
COMPLETED
Artemisinin-Based Antimalarial Combinations and Clinical Response in Cameroon
Lead Sponsor:
University of Yaounde 1
Collaborating Sponsors:
World Health Organization
Gates Malaria Partnership
Conditions:
Malaria
Eligibility:
All Genders
6-120 years
Phase:
PHASE3
Brief Summary
To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in comparison with artemether-lumefantrine during 42 days follow up period in 720 children with acute uncomplicated P....
Detailed Description
Methodology Children of either gender, between 6 months (\> 5kg) and 10 years of age, with acute uncomplicated P. falciparum infection, who fulfil all of the inclusion and have none of exclusion crite...
Eligibility Criteria
Inclusion
- Children of either gender, aged between 6 months (\> 5kg) and 10 years.
- Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using Giemsa-stained thick film with an asexual parasite density of 1,000 to 100,000 parasites/μl.
- Presenting with fever (axillary temperature ≥ 37.5oC) or having a history of fever in the preceding 24 hours.
- Able to ingest tablets orally (either suspended in water or uncrushed with food).
- Willing to participate in the study with written assent from parent/guardian. Parental authorization will be obtained for children less than 8 years old and documented assent of parents/guardians for children 8-10 years.
- Willing and able to attend the clinic on stipulated regular follow-up visits.
Exclusion
- •Any of the following "danger signs of severe malaria": Not able to drink or breast feed Persistent vomiting (\>2 episodes within previous 24 hours) Convulsions (\>1 episode within previous 24 hours) Lethargic/unconscious
- Signs/symptoms indicating severe/complicated malaria according to WHO criteria (WHO definition).
- Concomitant illnesses, underlying chronic hepatic or renal disease, abnormal cardiac rhythm, hypoglycaemia, jaundice, respiratory distress,
- Serious gastrointestinal disease, severe malnutrition (W/H \< 70%) or severe anaemia (haemoglobin \< 5 g/dl).
- Known hypersensitivity to the study drugs.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT01845701
Start Date
March 1 2010
End Date
April 1 2015
Last Update
September 26 2018
Active Locations (2)
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1
L'Hopital de District Ngong, Garoua,
Garoua, North Region, Cameroon
2
Baptist Hospital
Mutengene, South-West Region, Cameroon