Azithromycin Combination Therapy for the Treatment of Severe Malaria

Falciparum Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374126
• Other study ID #: PR-11019
• 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 =37.5ºC), 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:

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

• Falciparum Malaria
• Malaria
• Malaria, Falciparum

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