Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.
CAZAMS
A Randomized Trial of Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria in Tanzanian Children.
1 other identifier
interventional
261
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedOctober 20, 2016
March 1, 2009
6 months
June 5, 2008
October 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parasitological failure by day 28
Within 28 days of treatment.
Secondary Outcomes (2)
Combined clinical and parasitological outcome by day 42
42 days after treatment
Adverse events other than parasitologial failure.
42 days
Study Arms (2)
1AZ+AQ
EXPERIMENTALAzithromycin + artesunate
2AL
ACTIVE COMPARATORArtemether-lumefantrine
Interventions
Azithromycin 20mg/kg per day for three days (total 60 mg/kg) Artesunate 4mg/kg per day for 3 days
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
Eligibility Criteria
You may qualify if:
- Children with symptoms suggestive of malaria and
- P.falciparum of at least 2000 parasites per microL of blood
- are able to take study drugs by the oral route
- are able to attend stipulated days for follow up clinic and provide specimens
- have a parent or guardian who can give informed written/verbal consent to participate in the study
- aged 6-59 months.
You may not qualify if:
- severe and complicated forms of malaria (WHO, 2000)
- a mixed plasmodial infection
- 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).
- 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.
- known hypersensitivity to any of the trial drugs.
- live too far away for reliable follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Teule Hospital
Muheza, Tanga, Tanzania
Related Publications (1)
Sykes A, Hendriksen I, Mtove G, Mandea V, Mrema H, Rutta B, Mapunda E, Manjurano A, Amos B, Reyburn H, Whitty CJ. Azithromycin plus artesunate versus artemether-lumefantrine for treatment of uncomplicated malaria in Tanzanian children: a randomized, controlled trial. Clin Infect Dis. 2009 Oct 15;49(8):1195-201. doi: 10.1086/605635.
PMID: 19769536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Whitty
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 10, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2008
Study Completion
February 1, 2009
Last Updated
October 20, 2016
Record last verified: 2009-03