Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uncomplicated Falciparum Malaria
Intervention: azithromycin plus artesunate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Rashidul Haque, MBBS,PhD, Principal Investigator, Affiliation: ICDDR,B
Harald Noedl, MD, MCTM,PhD, Principal Investigator, Affiliation: Medical University of Vienna
Overall contact:
Harald Noedl, MD,MCTM,PhD, Phone: +43-1-4277-64882, Email: harald.noedl@meduniwien.ac.at
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.
Clinical Details
Official title: Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Primary clinical outcome is cure (ACPR as defined by WHO criteria) on Day 42.
Secondary outcome: Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).
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
Minimum age: 8 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Acute symptomatic falciparum malaria infection with a parasite density of 100 to
100,000 asexual parasites/L 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
Locations and Contacts
Harald Noedl, MD,MCTM,PhD, Phone: +43-1-4277-64882, Email: harald.noedl@meduniwien.ac.at
Sadar Hospital, Bandarban, Bangladesh; Recruiting
Rashidul Haque, MBBS, PhD, Principal Investigator
Harald Noedl, MD,MCTM,PhD, Principal Investigator
Aung Swi Prue Marma, MBBS, MPH, Sub-Investigator
Kamala Thriemer, MD, Sub-Investigator
Wasif Ali Khan, MD, Sub-Investigator
Additional Information
Starting date: August 2006
Last updated: September 6, 2006
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