Azithromycin + Artesunate v Artemether-Lumefantrine in Uncomplicated Malaria. - Full Text View

Sponsor:	Gates Malaria Partnership
Collaborators:	National Institute for Medical Research, Tanzania London School of Hygiene and Tropical Medicine
Information provided by:	Gates Malaria Partnership
ClinicalTrials.gov Identifier:	NCT00694694

Purpose

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	Intervention	Phase
Malaria	Drug: azithromycin + artesunate Drug: artemether-lumefantrine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study 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.

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Artemether Benflumetol Azithromycin Artesunate Co-artemether

U.S. FDA Resources

Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:

Parasitological failure by day 28 [ Time Frame: Within 28 days of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Combined clinical and parasitological outcome by day 42 [ Time Frame: 42 days after treatment ] [ Designated as safety issue: No ]
Adverse events other than parasitologial failure. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Enrollment:	261
Study Start Date:	June 2008
Study Completion Date:	February 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1AZ+AQ 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 Artemether-lumefantrine	Drug: artemether-lumefantrine 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 Other Names: coartem riamet

Show Detailed Description

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694694

Locations

Tanzania
Teule Hospital
Muheza, Tanga Region, Tanzania

Sponsors and Collaborators

Gates Malaria Partnership

National Institute for Medical Research, Tanzania

London School of Hygiene and Tropical Medicine

Investigators

Principal Investigator:

Christopher Whitty

London School of Hygiene and Tropical Medicine

More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Christopher Whitty, London School of Hygiene & Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00694694 History of Changes
Other Study ID Numbers:	ITCRVG50
Study First Received:	June 5, 2008
Last Updated:	March 5, 2009
Health Authority:	Tanzania: National Institute for Medical Research

Keywords provided by Gates Malaria Partnership:

Malaria
Africa
Child

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Artemisinins
Artesunate
Lumefantrine
Artemether-lumefantrine combination
Azithromycin
Antifungal Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Amebicides
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012