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Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh

This study has been completed.
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Armed Forces Research Institute of Medical Sciences, Thailand
Information provided by (Responsible Party):
Harald Noedl, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00356005
First received: July 24, 2006
Last updated: October 31, 2012
Last verified: October 2012
History of Changes

July 24, 2006
October 31, 2012
August 2006
August 2007   (final data collection date for primary outcome measure)
Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
Complete list of historical versions of study NCT00356005 on ClinicalTrials.gov Archive Site
Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT). [ Time Frame: 42 ] [ Designated as safety issue: No ]
Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).
Not Provided
Not Provided
 
Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh
Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Uncomplicated Falciparum Malaria
  • Drug: azithromycin plus artesunate
  • Drug: Artesunate
  • Experimental: Azithromycin + Artesunate
    Azithromycin + Artesunate treatment
    Intervention: Drug: azithromycin plus artesunate
  • Active Comparator: Artesunate
    Artesunate treatment controls
    Intervention: Drug: Artesunate
Thriemer K, Starzengruber P, Khan WA, Haque R, Marma AS, Ley B, Vossen MG, Swoboda P, Akter J, Noedl H. Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial. J Infect Dis. 2010 Aug 15;202(3):392-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
Not Provided
August 2007   (final data collection date for primary outcome measure)

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
Both
8 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Bangladesh
 
NCT00356005
ICDDRB #2006-024, MUW #218/2006
Not Provided
Harald Noedl, Medical University of Vienna
Medical University of Vienna
  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Armed Forces Research Institute of Medical Sciences, Thailand
Principal Investigator: Rashidul Haque, MBBS,PhD International Centre for Diarrhoeal Disease Research, Bangladesh
Principal Investigator: Harald Noedl, MD, MCTM,PhD Medical University of Vienna
Medical University of Vienna
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP