Clinical trial NCT00356005: Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh
Official title: Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Falciparum Malaria
Keywords: falciparum malaria
therapy
azithromycin
artesunate
Coartem
Bangladesh
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Armed Forces Research Institute of Medical Sciences, Thailand
First posted: 2006-07-25
Enrollment: 228
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.

Detailed description: In view of spreading antimalarial drug resistance there is an urgent need for new combination treatments for a disease that kills more than one million people every year. Azithromycin is a macrolide antibiotic that is particularly attractive due to its safety in children and experience with use in pregnancy. Recent trials suggest that azithromycin has a strong potential as an antimalarial. The purpose of this study is to investigate the efficacy of azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh.

Eligibility criteria: Inclusion Criteria:

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:

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 lumefantrine or to drugs with similar chemical structures
4. Malaria drug therapy administered in the past 30 days by history
5. Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
6. 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.
7. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
8. Signs or symptoms of severe malaria (as defined by WHO 2003)
9. Unable and/or unlikely to comprehend and/or follow the protocol

Primary outcomes:
measure: Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
timeFrame: 42 days
Secondary outcomes:
measure: Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).
timeFrame: 42
Other outcomes:
Locations:
city: Bandarban
country: Bangladesh
facility: Sadar Hospital
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Rashidul Haque, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Harald Noedl, MD, MCTM,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thriemer K, Starzengruber P, Khan WA, Haque R, Marma AS, Ley B, Vossen MG, Swoboda P, Akter J, Noedl H. Azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh: an open-label randomized, controlled clinical trial. J Infect Dis. 2010 Aug 15;202(3):392-8. doi: 10.1086/653710.