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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01374126
Other study ID # PR-11019
Secondary ID
Status Completed
Phase Phase 2
First received June 10, 2011
Last updated August 22, 2013
Start date July 2011
Est. completion date November 2012

Study information

Verified date August 2013
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Bangladesh: Ethical Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 65 Years
Eligibility 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 =37.5ÂșC), 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:

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

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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Artesunate
Artesunate alone
Azithromycin + Artesunate
Combination of azithromycin + artesunate

Locations

Country Name City State
Bangladesh MARIB Bandarban

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Vienna International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability (Number of Participants with Adverse Events) 42 days Yes
Primary Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42 42 days No
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