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Azithromycin Combination Therapy for the Treatment of Severe Malaria

NCT ID: NCT01374126

Last Updated: 2013-08-23

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Falciparum Malaria

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

Group Type EXPERIMENTAL

Azithromycin + Artesunate

Intervention Type DRUG

Combination of azithromycin + artesunate

Control (artesunate alone)

Group Type ACTIVE_COMPARATOR

Artesunate

Intervention Type DRUG

Artesunate alone

Interventions

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Artesunate

Artesunate alone

Intervention Type DRUG

Azithromycin + Artesunate

Combination of azithromycin + artesunate

Intervention Type DRUG

Eligibility Criteria

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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

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

Exclusion Criteria

Participants presenting with any of the following will not be included in the study:
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

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Harald Noedl

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MARIB

Bāndarban, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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PR-11019

Identifier Type: -

Identifier Source: org_study_id