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

October 31, 2012 updated by: Harald Noedl, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azithromycin + Artesunate
Azithromycin + Artesunate treatment
Drug: azithromycin plus artesunate
Active Comparator: Artesunate
Artesunate treatment controls
Drug: Artesunate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).
Time Frame: 42
42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 25, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICDDRB #2006-024
  • MUW #218/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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