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Malaria, FalciparumPhase 1/2NCT00147368

Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

A Phase 1/2 study testing intravenous (IV) arginine in people with Malaria, Falciparum, run by Menzies School of Health Research at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Malaria, Falciparum
What is being tested?
intravenous (IV) arginine
Type of treatment
Injection or infusion
How many people
50 participants
Where
1 siteIndonesia
Study dates
Feb 2005to Dec 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • RSMM Hospital

    Timika

Other trials in Indonesia

About this study

Official title: 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.

Being tested
intravenous (IV) arginine
Keywords
falciparum, malaria, arginine
Medical subject headings
Malaria, Falciparum, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravenous (IV) arginineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. exhaled and systemic nitric oxide production

  2. endothelial function

Secondary outcomes (7)

  1. safety

  2. pharmacokinetic (PK) parameters

  3. pharmacodynamic (PD) parameters

  4. oxidant stress

  5. gas transfer

  6. endothelial activation

  7. a priori subgroup analysis: endothelial function in those with baseline impairment of function

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionApr 2006
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147368
Sponsor's protocol ID
arginine
Other IDs
GR071614MA - Wellcome Trust
Status last verified
May 2008
First submitted
6 Sep 2005
Last updated
2 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Yeo TW, Lampah DA, Gitawati R, Tjitra E, Kenangalem E, McNeil YR, Darcy CJ, Granger DL, Weinberg JB, Lopansri BK, Price RN, Duffull SB, Celermajer DS, Anstey NM. Impaired nitric oxide bioavailability and L-arginine reversible endothelial dysfunction in adults with falciparum malaria. J Exp Med. 2007 Oct 29;204(11):2693-704. doi: 10.1084/jem.20070819. Epub 2007 Oct 22.

    PubMed 17954570

  • Yeo TW, Lampah DA, Gitawati R, Tjitra E, Kenangalem E, Granger DL, Weinberg JB, Lopansri BK, Price RN, Celermajer DS, Duffull SB, Anstey NM. Safety profile of L-arginine infusion in moderately severe falciparum malaria. PLoS One. 2008 Jun 11;3(6):e2347. doi: 10.1371/journal.pone.0002347.

    PubMed 18545693

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing intravenous (IV) arginine in people with Malaria, Falciparum, run by Menzies School of Health Research at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

exhaled and systemic nitric oxide production. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00147368, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2008.

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