Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. (CAZAMS)
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|ClinicalTrials.gov Identifier: NCT00694694|
Recruitment Status : Completed
First Posted : June 10, 2008
Last Update Posted : October 20, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: azithromycin + artesunate Drug: artemether-lumefantrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Trial of Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria in Tanzanian Children.|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||February 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694694
|Muheza, Tanga Region, Tanzania|
|Principal Investigator:||Christopher Whitty||London School of Hygiene and Tropical Medicine|