Status:
COMPLETED
Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
National Institute for Medical Research, Tanzania
Conditions:
Malaria
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
Brief Summary
This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantr...
Detailed Description
Trial drugs. Artemether-lumefantrine (AL) has been selected to be the drug used to treat uncomplicated malaria in Tanzania. There is extensive efficacy, effectiveness and safety data on this combinati...
Eligibility Criteria
Inclusion
- Children with symptoms suggestive of malaria and
- P.falciparum of at least 2000 parasites per microL of blood
- are able to take study drugs by the oral route
- are able to attend stipulated days for follow up clinic and provide specimens
- have a parent or guardian who can give informed written/verbal consent to participate in the study
- aged 6-59 months.
Exclusion
- severe and complicated forms of malaria (WHO, 2000)
- a mixed plasmodial infection
- a concomitant disease masking assessment of the treatment response (cases in whom advanced HIV infection is suspected will lead to be referred for HIV counseling).
- recent effective full dose antimalarial treatment (within 7 days), excluding chloroquine, SP and AQ which have \>70% failure in this district, or combinations of these.
- known hypersensitivity to any of the trial drugs.
- live too far away for reliable follow-up
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00694694
Start Date
June 1 2008
End Date
February 1 2009
Last Update
October 20 2016
Active Locations (1)
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1
Teule Hospital
Muheza, Tanga, Tanzania