Overview

Artemisinin Resistance in Bangladesh

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Vienna
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
World Health Organization
Treatments:
Artemisinine
Artemisinins
Artesunate
Doxycycline
Quinine
Criteria
Inclusion Criteria:

1. Acute symptomatic falciparum malaria infection as determined by malaria smear with a
parasite density of 1,000 to 100,000 asexual parasites/uL as determined on the
screening smear with fever (defined as ≥37.5C), or reported history of fever within
the last 48 hours.

2. Age: 8-65 years old

3. All females between the age of 12 and 50 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 throughout the study

4. Written informed consent obtained

5. Willing to stay under close medical supervision for the study duration of 42 days

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

2. Mixed malaria infection on admission by malaria smear

3. A previous history of intolerance or hypersensitivity to the study drugs 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 2000)

8. Unable and/or unlikely to comprehend and/or follow the protocol