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
  Purpose

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.


Condition Intervention Phase
Falciparum Malaria
Drug: Artesunate
Drug: Azithromycin + 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 Severe Malaria - A Pilot Safety and Efficacy Study in Uncomplicated Falciparum Malaria in Bangladesh

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Enrollment: 75
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin-Artesunate Drug: Azithromycin + Artesunate
Combination of azithromycin + artesunate
Active Comparator: Control (artesunate alone) Drug: Artesunate
Artesunate alone

  Eligibility

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

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
  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: NCT01374126

Locations
Bangladesh
MARIB
Bandarban, Bangladesh
Sponsors and Collaborators
Medical University of Vienna
International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: Harald Noedl, Assoc. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01374126     History of Changes
Other Study ID Numbers: PR-11019
Study First Received: June 10, 2011
Last Updated: August 22, 2013
Health Authority: Bangladesh: Ethical Review Committee

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 22, 2014