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
  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
Drug: Artesunate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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. [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT). [ Time Frame: 42 ] [ Designated as safety issue: No ]

Enrollment: 228
Study Start Date: August 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin + Artesunate
Azithromycin + Artesunate treatment
Drug: azithromycin plus artesunate
Active Comparator: Artesunate
Artesunate treatment controls
Drug: Artesunate

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 International Centre for Diarrhoeal Disease Research, Bangladesh
Principal Investigator: Harald Noedl, MD, MCTM,PhD Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harald Noedl, Assoc. Prof., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00356005     History of Changes
Other Study ID Numbers: ICDDRB #2006-024, MUW #218/2006
Study First Received: July 24, 2006
Last Updated: October 31, 2012
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:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Azithromycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014