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Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

Pharmacokinetic-Pharmacodynamic Study of Adjunctive Arginine in Falciparum Malaria

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00147368
Enrollment
50
Registered
2005-09-07
Start date
2005-02-28
Completion date
2007-12-31
Last updated
2008-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Falciparum

Keywords

falciparum, malaria, arginine

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.

Interventions

DRUGintravenous (IV) arginine

Sponsors

Wellcome Trust
CollaboratorOTHER
National Health and Medical Research Council, Australia
CollaboratorOTHER
MSHR
CollaboratorUNKNOWN
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
CollaboratorOTHER
Rumah Sakit Mitra Masyarakat Hospital
CollaboratorOTHER
University of Utah
CollaboratorOTHER
University of Sydney
CollaboratorOTHER
Menzies School of Health Research
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Ages 18-60 years 2. P. falciparum parasitemia (1,000-100,000 parasites/ul). 3. 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 4. Commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine 5. 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) 6. Informed consent obtained

Design outcomes

Primary

MeasureTime frame
exhaled and systemic nitric oxide production—
endothelial function—

Secondary

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026