Azithromycin Combination Therapy for the Treatment of Severe Malaria

This study has been completed.
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Harald Noedl, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01374126
First received: June 10, 2011
Last updated: August 22, 2013
Last verified: August 2013

June 10, 2011
August 22, 2013
July 2011
November 2012   (final data collection date for primary outcome measure)
  • Safety and Tolerability (Number of Participants with Adverse Events) [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01374126 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Azithromycin Combination Therapy for the Treatment of Severe Malaria
Azithromycin Combination Therapy for the Treatment of Severe Malaria - A Pilot Safety and Efficacy Study in Uncomplicated Falciparum Malaria in Bangladesh

A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Falciparum Malaria
  • Drug: Artesunate
    Artesunate alone
  • Drug: Azithromycin + Artesunate
    Combination of azithromycin + artesunate
  • Experimental: Azithromycin-Artesunate
    Intervention: Drug: Azithromycin + Artesunate
  • Active Comparator: Control (artesunate alone)
    Intervention: Drug: Artesunate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Male and female participants with a diagnosis of acute falciparum malaria meeting all criteria listed below may be included in the study:

  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:

Participants presenting with any of the following will not be included in the study:

  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 to drugs with similar chemical structures
  4. Malaria drug therapy administered in the past 30 days by history
  5. 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.
  6. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
  7. Signs or symptoms of severe malaria (as defined by WHO 2003)
  8. 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
 
NCT01374126
PR-11019
Not Provided
Harald Noedl, Medical University of Vienna
Medical University of Vienna
International Centre for Diarrhoeal Disease Research, Bangladesh
Not Provided
Medical University of Vienna
August 2013

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