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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT00356005
• Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh (Other), Armed Forces Research Institute of Medical Sciences, Thailand (Other)
• Enrollment: 228
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated Falciparum Malaria	Drug: azithromycin plus artesunate; Drug: Artesunate	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Aug 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42. [42 days]

Secondary Outcome Measures

1. Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT). [42]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Harald Noedl, Assoc. Prof., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT00356005
• Other Study ID Numbers: ICDDRB #2006-024; MUW #218/2006
• First Posted: Jul 25, 2006
• Last Update Posted: Nov 1, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Harald Noedl, Assoc. Prof., Medical University of Vienna: falciparum malaria; therapy; azithromycin; artesunate; Coartem; Bangladesh
• Additional relevant MeSH terms: Malaria; Malaria, Falciparum; Azithromycin; Artesunate

Study Results

No Results Posted as of Nov 1, 2012