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Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh
This study has been completed.
First Received: July 24, 2006   Last Updated: July 29, 2008   History of Changes
Sponsor: Medical University of Vienna
Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
Armed Forces Research Institute of Medical Sciences, Thailand
Information provided by: Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00356005
  Purpose

The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.


Condition Intervention Phase
Uncomplicated Falciparum Malaria
Drug: azithromycin plus artesunate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.

Secondary Outcome Measures:
  • Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).

Enrollment: 228
Study Start Date: August 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

In view of spreading antimalarial drug resistance there is an urgent need for new combination treatments for a disease that kills more than one million people every year. Azithromycin is a macrolide antibiotic that is particularly attractive due to its safety in children and experience with use in pregnancy. Recent trials suggest that azithromycin has a strong potential as an antimalarial. The purpose of this study is to investigate the efficacy of azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh.

  Eligibility

Ages Eligible for Study:   8 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute symptomatic falciparum malaria infection with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5ºC), or reported history of fever within the last 48 hours.
  2. Age: 8-65 years old
  3. Males or females. All females over the age of 12 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
  4. Written informed consent obtained
  5. Willing to stay under close medical supervision for the study duration
  6. Otherwise healthy outpatients

Exclusion Criteria:

  1. Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3)
  2. Mixed malaria infection on admission by malaria smear
  3. A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin, or lumefantrine or to drugs with similar chemical structures
  4. Malaria drug therapy administered in the past 30 days by history
  5. Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
  6. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
  7. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
  8. Signs or symptoms of severe malaria (as defined by WHO 2003)
  9. Unable and/or unlikely to comprehend and/or follow the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356005

Locations
Bangladesh
Sadar Hospital
Bandarban, Bangladesh
Sponsors and Collaborators
Medical University of Vienna
International Centre for Diarrhoeal Disease Research, Bangladesh
Armed Forces Research Institute of Medical Sciences, Thailand
Investigators
Principal Investigator: Rashidul Haque, MBBS,PhD ICDDR, B
Principal Investigator: Harald Noedl, MD, MCTM,PhD Medical University of Vienna
  More Information

No publications provided

Study ID Numbers: ICDDRB #2006-024, MUW #218/2006
Study First Received: July 24, 2006
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00356005     History of Changes
Health Authority: Bangladesh: Ethical Review Committee;   Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
falciparum malaria
therapy
azithromycin
artesunate
Coartem
Bangladesh

Additional relevant MeSH terms:
Artesunate
Protozoan Infections
Anti-Infective Agents
Antiprotozoal Agents
Coccidiosis
Malaria
Pharmacologic Actions
Malaria, Falciparum
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Azithromycin
Therapeutic Uses
Parasitic Diseases
Amebicides

ClinicalTrials.gov processed this record on February 08, 2010