Status:
COMPLETED
Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
Wellcome Trust
National Health and Medical Research Council, Australia
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 escal...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnancy or lactation
- Mixed infection with P. falciparum and P. vivax
- Warning signs of altered mental state and inability to sit unaided
- Features of severe/complicated malaria
- Diabetes
- Systolic blood pressure (BP) \< 100 mmHg
- Serious underlying disease (cardiac, hepatic, kidney)
- Initial iSTAT test showing any of the following values:
- glucose \< 4 mmol/L;
- K+ ≥ 4.2 meq/L;
- Cl- \> 106 meq/L;
- HCO3- \< 20 meq/L.
- Known allergy to L-arginine
- Concurrent therapy with any of the following medications:
- spironolactone;
- oral nitrates;
- phosphodiesterase inhibitor (eg sildenafil \[Viagra\]);
- alpha-blocking antihypertensive agents (eg prazosin);
- L-arginine.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00147368
Start Date
February 1 2005
End Date
December 1 2007
Last Update
June 2 2008
Active Locations (1)
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1
RSMM Hospital
Timika, Indonesia