Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2008-12
- Completion
- 2009-02
Outcome
Missed primary endpoint
paper 69 (58%) of 119 children in the AZ+AS arm and 24 (20%) of 120 in the AL arm had asexual parasites at or by day 28 PMID 19769536 ↗
paper adjusted odds ratio for failure with AZ+AS treatment, 6.1; 95% confidence interval, 3.3-11.4; P < .001 PMID 19769536 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether | Small molecule | 20 mg | Oral |
| Subject | Artesunate | Small molecule | 4 mg/kg | Oral |
| Subject | Azithromycin | Small molecule | 20 mg/kg | Oral |
| Comparator | lumefantrine | Small molecule | 120 mg | Oral |