Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. (CAZAMS)
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
- there are only a limited range of drug combinations which work against malaria in this area of Tanzania
- 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.
|Malaria||Drug: azithromycin + artesunate Drug: artemether-lumefantrine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria in Tanzanian Children.|
- Parasitological failure by day 28 [ Time Frame: Within 28 days of treatment. ]
- Combined clinical and parasitological outcome by day 42 [ Time Frame: 42 days after treatment ]
- Adverse events other than parasitologial failure. [ Time Frame: 42 days ]
|Study Start Date:||June 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Azithromycin + artesunate
Drug: azithromycin + artesunate
Azithromycin 20mg/kg per day for three days (total 60 mg/kg) Artesunate 4mg/kg per day for 3 days
Other Name: zithromax
Active Comparator: 2AL
Tablets are fixed-dose combinations and contain 20mg artemether and 120mg lumefantrine.
For children 5-14.9kg 1 tab 2x a day for 3 days For children 15-24.9kg 2 tablets 2x a day for 3 days For children 25-35kg 3 tablets 2x a day for 3 days
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694694
|Muheza, Tanga Region, Tanzania|
|Principal Investigator:||Christopher Whitty||London School of Hygiene and Tropical Medicine|