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Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

NCT00147368 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-06-02

No results posted yet for this study

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.

Conditions

  • Malaria, Falciparum

Interventions

DRUG

intravenous (IV) arginine

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • MSHR

    collaborator UNKNOWN

  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

    collaborator OTHER

  • Rumah Sakit Mitra Masyarakat Hospital

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of Sydney

    collaborator OTHER

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • Nick M Anstey, MBBS · MSHR

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-04-30
Completion
2007-12-31

Countries

  • Indonesia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00147368 on ClinicalTrials.gov