Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria, Falciparum

Keywords

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falciparum malaria arginine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intravenous (IV) arginine

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

6. Informed consent obtained

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Menzies School of Health Research

Principal Investigators

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Nick M Anstey, MBBS

Role: PRINCIPAL_INVESTIGATOR

MSHR

Locations

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RSMM Hospital

Timika, , Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND

PMID: 17954570 (View on PubMed)

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.

Reference Type DERIVED

PMID: 18545693 (View on PubMed)

Other Identifiers

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GR071614MA - Wellcome Trust

Identifier Type: -

Identifier Source: secondary_id

arginine