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

Original Study ID : ICDDRB #2006-024

Secondary ID : MUW #218/2006

NCT ID : NCT00356005

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

Official Title : Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial

Brief Summary :

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.

Source : Medical University of Vienna

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.

Overall Status : Completed

Start Date : August 2006

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Enrollment : 228

Verification Date : July 2008

First Received Date : July 24, 2006

Trial Eligibility

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

Gender : Both

Minimum Age : 8 Years

Maximum Age : 65 Years

Healthy Volunteers : No

Facilities

Facility Name : Sadar Hospital

City : Bandarban

Country : Bangladesh

OutComes

Primary OutComes

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

Secondary OutComes

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

Interventions

Type : Drug

Name : azithromycin plus artesunate

Clinical Trial Name - Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Banglade