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Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. (CAZAMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694694
First Posted: June 10, 2008
Last Update Posted: October 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute for Medical Research, Tanzania
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
  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

  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.


Condition Intervention Phase
Malaria Drug: azithromycin + artesunate Drug: artemether-lumefantrine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Parasitological failure by day 28 [ Time Frame: Within 28 days of treatment. ]

Secondary Outcome Measures:
  • Combined clinical and parasitological outcome by day 42 [ Time Frame: 42 days after treatment ]
  • Adverse events other than parasitologial failure. [ Time Frame: 42 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children with symptoms suggestive of malaria and

  1. P.falciparum of at least 2000 parasites per microL of blood
  2. are able to take study drugs by the oral route
  3. are able to attend stipulated days for follow up clinic and provide specimens
  4. have a parent or guardian who can give informed written/verbal consent to participate in the study
  5. aged 6-59 months.

Exclusion Criteria:

  1. severe and complicated forms of malaria (WHO, 2000)
  2. a mixed plasmodial infection
  3. 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).
  4. 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.
  5. known hypersensitivity to any of the trial drugs.
  6. live too far away for reliable follow-up
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Tanzania
Teule Hospital
Muheza, Tanga Region, Tanzania
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
National Institute for Medical Research, Tanzania
Investigators
Principal Investigator: Christopher Whitty London School of Hygiene and Tropical Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00694694     History of Changes
Other Study ID Numbers: ITCRVG50
First Submitted: June 5, 2008
First Posted: June 10, 2008
Last Update Posted: October 20, 2016
Last Verified: March 2009

Keywords provided by London School of Hygiene and Tropical Medicine:
Malaria
Africa
Child

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Lumefantrine
Artemether
Artemether-lumefantrine combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics