drugset / Trial / NCT00147368
Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria
Phase 1/2
Completed
50 enrolled
Menzies School of Health Research
MSHR · collabNational Health and Medical Research Council, Australia · collabNational Institute of Health Research and Development, Ministry of Health Republic of Indonesia · collabRumah Sakit Mitra Masyarakat Hospital · collabUniversity of Sydney · collabUniversity of Utah · collabWellcome Trust · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-02
- Primary completion
- 2006-04
- Completion
- 2007-12
Publications
- Background Yeo TW, Lampah DA, Gitawati R, Tjitra E, Kenangalem E, McNeil YR, Darcy CJ, Granger DL, Weinberg JB, Lopansri BK, Price RN, Duffull SB, Celermajer DS, Anstey NM. Impaired nitric oxide bioavailability and L-arginine reversible endothelial dysfunction in adults with falciparum malaria. J Exp Med. 2007 Oct 29;204(11):2693-704. doi: 10.1084/jem.20070819. Epub 2007 Oct 22.
- Yeo TW, Lampah DA, Gitawati R, Tjitra E, Kenangalem E, Granger DL, Weinberg JB, Lopansri BK, Price RN, Celermajer DS, Duffull SB, Anstey NM. Safety profile of L-arginine infusion in moderately severe falciparum malaria. PLoS One. 2008 Jun 11;3(6):e2347. doi: 10.1371/journal.pone.0002347.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L-arginine | Small molecule | 3 g | Intravenous |
| Subject | L-arginine | Small molecule | 6 g | Intravenous |
| Subject | L-arginine | Small molecule | 12 g | Intravenous |