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

NCT ID: NCT00356005

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Uncomplicated Falciparum Malaria

Keywords

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falciparum malaria therapy azithromycin artesunate Coartem Bangladesh

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin + Artesunate

Azithromycin + Artesunate treatment

Group Type EXPERIMENTAL

azithromycin plus artesunate

Intervention Type DRUG

Artesunate

Artesunate treatment controls

Group Type ACTIVE_COMPARATOR

Artesunate

Intervention Type DRUG

Interventions

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azithromycin plus artesunate

Intervention Type DRUG

Artesunate

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

Armed Forces Research Institute of Medical Sciences, Thailand

OTHER_GOV

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Harald Noedl

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rashidul Haque, MBBS,PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Harald Noedl, MD, MCTM,PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Sadar Hospital

Bāndarban, , Bangladesh

Site Status

Countries

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Bangladesh

References

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Thriemer K, Starzengruber P, Khan WA, Haque R, Marma AS, Ley B, Vossen MG, Swoboda P, Akter J, Noedl H. Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial. J Infect Dis. 2010 Aug 15;202(3):392-8. doi: 10.1086/653710.

Reference Type DERIVED
PMID: 20557237 (View on PubMed)

Other Identifiers

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MUW #218/2006

Identifier Type: -

Identifier Source: secondary_id

ICDDRB #2006-024

Identifier Type: -

Identifier Source: org_study_id