Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: National Institute for Medical Research, Tanzania
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Azithromycin; Lumefantrine

Criteria

Inclusion Criteria:

Children with symptoms suggestive of malaria and

1. P.falciparum of at least 2000 parasites per microL of blood

2. are able to take study drugs by the oral route

3. are able to attend stipulated days for follow up clinic and provide specimens

4. have a parent or guardian who can give informed written/verbal consent to participate in the study

5. aged 6-59 months.

Exclusion Criteria:

1. severe and complicated forms of malaria (WHO, 2000)

2. a mixed plasmodial infection

3. 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).

4. 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.

5. known hypersensitivity to any of the trial drugs.

6. live too far away for reliable follow-up