Clinical Trial: Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pharmacokinetic-Pharmacodynamic Study of Adjunctive Arginine in Falciparum Malaria

Brief Summary: 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.

Detailed Summary:
Sponsor: Menzies School of Health Research

Current Primary Outcome:

  • exhaled and systemic nitric oxide production
  • endothelial function


Original Primary Outcome:

  • 1. exhaled and systemic nitric oxide production
  • 2. endothelial function


Current Secondary Outcome:

  • safety
  • pharmacokinetic (PK) parameters
  • pharmacodynamic (PD) parameters
  • oxidant stress
  • gas transfer
  • endothelial activation
  • a priori subgroup analysis: endothelial function in those with baseline impairment of function


Original Secondary Outcome:

  • 1. safety
  • 2. PK parameters
  • 3. PD parameters
  • 4. oxidant stress
  • 5. gas transfer
  • 6. endothelial activation
  • 6. a priori subgroup analysis: endothelial function in those with baseline impairment of function


Information By: Menzies School of Health Research

Dates:
Date Received: September 6, 2005
Date Started: February 2005
Date Completion:
Last Updated: May 30, 2008
Last Verified: May 2008