Azithromycin Combination Therapy for the Treatment of Severe Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01374126
• Date of registration: 10/06/2011
• Prospective Registration: Yes
• Primary sponsor: Medical University of Vienna
• Public title: Azithromycin Combination Therapy for the Treatment of Severe Malaria
• Scientific title: Azithromycin Combination Therapy for the Treatment of Severe Malaria - A Pilot Safety and Efficacy Study in Uncomplicated Falciparum Malaria in Bangladesh
• Date of first enrolment: July 2011
• Target sample size: 75
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01374126
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Bangladesh

Key inclusion & exclusion 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:

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



Age minimum: 8 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Falciparum Malaria

Intervention(s)

Drug: Artesunate

Drug: Azithromycin + Artesunate

Primary Outcome(s)

Safety and Tolerability (Number of Participants with Adverse Events) [Time Frame: 42 days]

Adequate Clinical and Parasitological Response (ACPR) on Days 28 and 42 [Time Frame: 42 days]

Secondary ID(s)

PR-11019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Centre for Diarrhoeal Disease Research, Bangladesh