Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
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-lumefantrine (AL). There are two reasons this is important
1. there are only a limited range of drug combinations which work against malaria in this
area of Tanzania
2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if
the combination is an effective antimalarial it might have a place where there are no
diagnostic facilities as syndromic treatment for fever.
Artesunate and azithromycin have both been used alone or in combination with other drugs in
children in Tanzania for many years, and are considered safe. There is trial evidence for the
effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory)
evidence that it works against the malaria parasite.
The trial randomizes children with non-severe malaria to the new combination AZ+AS or the
standard care arm AL. The primary outcome is the parasitological failure rate by day 28-
meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary
outcomes include safety.