Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

May 30, 2008 updated by: Menzies School of Health Research

Pharmacokinetic-Pharmacodynamic Study of Adjunctive Arginine in Falciparum Malaria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Mixed infection with P. falciparum and P. vivax
  3. Warning signs of altered mental state and inability to sit unaided
  4. Features of severe/complicated malaria
  5. Diabetes
  6. Systolic blood pressure (BP) < 100 mmHg
  7. Serious underlying disease (cardiac, hepatic, kidney)

  8. 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.
  9. Known allergy to L-arginine

  10. Concurrent therapy with any of the following medications:

    • spironolactone;
    • oral nitrates;
    • phosphodiesterase inhibitor (eg sildenafil [Viagra]);
    • alpha-blocking antihypertensive agents (eg prazosin);
    • L-arginine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
exhaled and systemic nitric oxide production
endothelial function

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menzies School of Health Research

Collaborators

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

Investigators

  • Principal Investigator: Nick M Anstey, MBBS, MSHR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

June 2, 2008

Last Update Submitted That Met QC Criteria

May 30, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • arginine
  • GR071614MA - Wellcome Trust

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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