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Sponsors and Collaborators: |
Menzies School of Health Research Wellcome Trust National Health and Medical Research Council, Australia MSHR NIHRD Rumah Sakit Mitra Masyarakat Hospital University of Utah University of Sydney |
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Information provided by: | Menzies School of Health Research |
ClinicalTrials.gov Identifier: | NCT00147368 |
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.
Condition | Intervention | Phase |
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Malaria, Falciparum |
Drug: intravenous (IV) arginine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Pharmacokinetic-Pharmacodynamic Study of Adjunctive Arginine in Falciparum Malaria |
Estimated Enrollment: | 50 |
Study Start Date: | February 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Initial iSTAT test showing any of the following values:
Concurrent therapy with any of the following medications:
Indonesia | |
RSMM Hospital | |
Timika, Indonesia |
Principal Investigator: | Nick M Anstey, MBBS | MSHR |
Responsible Party: | Menzies School of Health Research ( Nicholas Anstey ) |
Study ID Numbers: | arginine, GR071614MA - Wellcome Trust |
Study First Received: | September 6, 2005 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00147368 |
Health Authority: | Australia: Human Research Ethics Committee |
falciparum malaria arginine |
Protozoan Infections Parasitic Diseases Malaria Malaria, Falciparum |
Coccidiosis |