Status:
SUSPENDED
Safety and Preliminary Efficacy of L-arginine in Severe Falciparum Malaria
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
Wellcome Trust
National Health and Medical Research Council, Australia
Conditions:
Severe Falciparum Malaria
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Background: Mortality from severe malaria remains \~15% despite the use of the most rapidly parasiticidal antimalarial therapy, artesunate. Adjunctive treatments may improve outcome. Our overall goal ...
Detailed Description
See brief summary
Eligibility Criteria
Inclusion
- age 18-60 years
- informed consent obtained
- time of commencement of artesunate ≤18 hrs before infusion of L-arginine
- any level of P. falciparum parasitemia, and one or more of the following criteria: i. acute renal failure (creatinine \>265umol/L) ii. hyperbilirubinemia (total bilirubin \>50 umol/L) with either renal impairment (creatinine \>130umol/L) or parasitemia of \>100,000 parasites/uL iii. blackwater fever iv. hyperparasitemia (\>10% parasitised red cells) v. cerebral malaria (Glasgow coma score \<11) vi. Hypoglycemia vii. Respiratory distress (RR \>32)
Exclusion
- pregnancy or lactation
- diabetes
- serious pre-existing disease (cardiac, hepatic, kidney)
- systolic blood pressure \<90 mmHg after fluid resuscitation
- initial iSTAT test showing any of the following values: i. K+ \> 5.5 meq/L ii. Cl- \> 110 meq/L iii. HCO3- \< 15 meq/L
- known allergy to L-arginine
- evidence of concurrent bacterial infection
- concurrent therapy with any of the following medications: iv. spironolactone, v. oral nitrates, vi. phosphodiesterase inhibitor (eg sildenafil \[Viagra\]) vii. alpha-blocking antihypertensive agents (eg prazosin) viii. L-arginine
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00616304
Start Date
February 1 2008
Last Update
March 13 2024
Active Locations (1)
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1
Mitra Masyarakat Hospital
Timika, Special Region of Papua, Indonesia