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Azithromycin Combination Therapy for the Treatment of Severe Malaria

Primary Purpose

Falciparum Malaria

Status

Completed

Phase

Phase 2

Locations

Bangladesh

Study Type

Interventional

Intervention

Artesunate

Azithromycin + Artesunate

About this trial

This is an interventional treatment trial for Falciparum Malaria

Eligibility Criteria

8 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female participants with a diagnosis of acute falciparum malaria meeting all criteria listed below may be included in the study:

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.
Age: 8-65 years old
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
Written informed consent obtained
Willing to stay under close medical supervision for the study duration
Otherwise healthy outpatients

Exclusion Criteria:

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

Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3)
Mixed malaria infection on admission by malaria smear
A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin or to drugs with similar chemical structures
Malaria drug therapy administered in the past 30 days by history
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.
Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
Signs or symptoms of severe malaria (as defined by WHO 2003)
Unable and/or unlikely to comprehend and/or follow the protocol

Sites / Locations

MARIB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azithromycin-Artesunate

Control (artesunate alone)

Arm Description

Outcomes

Primary Outcome Measures

Safety and Tolerability (Number of Participants with Adverse Events)

Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42

Secondary Outcome Measures

Full Information

NCT ID

NCT01374126

First Posted

June 10, 2011

Last Updated

August 22, 2013

Sponsor

Medical University of Vienna

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

1. Study Identification

Unique Protocol Identification Number

NCT01374126

Brief Title

Azithromycin Combination Therapy for the Treatment of Severe Malaria

Official Title

Azithromycin Combination Therapy for the Treatment of Severe Malaria - A Pilot Safety and Efficacy Study in Uncomplicated Falciparum Malaria in Bangladesh

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Falciparum Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Azithromycin-Artesunate

Arm Type

Experimental

Arm Title

Control (artesunate alone)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Artesunate

Intervention Description

Artesunate alone

Intervention Type

Drug

Intervention Name(s)

Azithromycin + Artesunate

Intervention Description

Combination of azithromycin + artesunate

Primary Outcome Measure Information:

Title

Safety and Tolerability (Number of Participants with Adverse Events)

Time Frame

42 days

Title

Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female participants with a diagnosis of acute falciparum malaria meeting all criteria listed below may be included in the study: 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. Age: 8-65 years old 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 Written informed consent obtained Willing to stay under close medical supervision for the study duration Otherwise healthy outpatients Exclusion Criteria: Participants presenting with any of the following will not be included in the study: Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3) Mixed malaria infection on admission by malaria smear A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin or to drugs with similar chemical structures Malaria drug therapy administered in the past 30 days by history 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. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours). Signs or symptoms of severe malaria (as defined by WHO 2003) Unable and/or unlikely to comprehend and/or follow the protocol

Facility Information:

Facility Name

MARIB

City

Bandarban

Country

Bangladesh

12. IPD Sharing Statement

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Azithromycin Combination Therapy for the Treatment of Severe Malaria

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