Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria
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ClinicalTrials.gov Identifier: NCT00147368
Recruitment Status :
First Posted : September 7, 2005
Last Update Posted : June 2, 2008
Menzies School of Health Research
National Health and Medical Research Council, Australia
National Institute of Health Research and Development (NIHRD), Indonesia
Acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide (NO) production. Both are associated with poor outcome. This study will examine the safety and effect of escalating doses of arginine in falciparum malaria. It will determine whether arginine can increase NO production and have an effect on NO-dependent physiological measurements. The hypothesis is that arginine: will be safe in falciparum malaria; will return plasma arginine concentration to normal/supranormal levels; will increase systemic and exhaled NO; reduces oxidant stress; and improves a number of NO-dependent physiological measures of relevance to malaria.
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Ages 18-60 years
P. falciparum parasitemia (1,000-100,000 parasites/ul).
Clinical syndrome consistent with malaria associated with documented fever (axillary temperature > 38℃) or self-reported history of fever in the last 48 hours with no other cause present
Commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine
An indication for hospital admission (eg relative cannot look after/supervise treatment at home but not having any warning signs or severe malaria criteria in "exclusion criteria" below)
Informed consent obtained
Pregnancy or lactation
Mixed infection with P. falciparum and P. vivax
Warning signs of altered mental state and inability to sit unaided