Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT00147368
Status:
COMPLETED
Last Update Posted:
2008-06-02
First Post:
2005-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-30', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exhaled and systemic nitric oxide production'}, {'measure': 'endothelial function'}], 'secondaryOutcomes': [{'measure': 'safety'}, {'measure': 'pharmacokinetic (PK) parameters'}, {'measure': 'pharmacodynamic (PD) parameters'}, {'measure': 'oxidant stress'}, {'measure': 'gas transfer'}, {'measure': 'endothelial activation'}, {'measure': 'a priori subgroup analysis: endothelial function in those with baseline impairment of function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['falciparum', 'malaria', 'arginine'], 'conditions': ['Malaria, Falciparum']}, 'referencesModule': {'references': [{'pmid': '17954570', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18545693', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18-60 years\n2. P. falciparum parasitemia (1,000-100,000 parasites/ul).\n3. 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\n4. Commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine\n5. 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)\n6. Informed consent obtained\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Mixed infection with P. falciparum and P. vivax\n3. Warning signs of altered mental state and inability to sit unaided\n4. Features of severe/complicated malaria\n5. Diabetes\n6. Systolic blood pressure (BP) \\< 100 mmHg\n7. Serious underlying disease (cardiac, hepatic, kidney)\n8. Initial iSTAT test showing any of the following values:\n\n * glucose \\< 4 mmol/L;\n * K+ ≥ 4.2 meq/L;\n * Cl- \\> 106 meq/L;\n * HCO3- \\< 20 meq/L.\n9. Known allergy to L-arginine\n10. Concurrent therapy with any of the following medications:\n\n * spironolactone;\n * oral nitrates;\n * phosphodiesterase inhibitor (eg sildenafil \\[Viagra\\]);\n * alpha-blocking antihypertensive agents (eg prazosin);\n * L-arginine.'}, 'identificationModule': {'nctId': 'NCT00147368', 'briefTitle': 'Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria', 'organization': {'class': 'OTHER', 'fullName': 'Menzies School of Health Research'}, 'officialTitle': 'Pharmacokinetic-Pharmacodynamic Study of Adjunctive Arginine in Falciparum Malaria', 'orgStudyIdInfo': {'id': 'arginine'}, 'secondaryIdInfos': [{'id': 'GR071614MA - Wellcome Trust'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'intravenous (IV) arginine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Timika', 'country': 'Indonesia', 'facility': 'RSMM Hospital', 'geoPoint': {'lat': -4.61407, 'lon': 136.67679}}], 'overallOfficials': [{'name': 'Nick M Anstey, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MSHR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menzies School of Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}, {'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}, {'name': 'MSHR', 'class': 'UNKNOWN'}, {'name': 'National Institute of Health Research and Development, Ministry of Health Republic of Indonesia', 'class': 'OTHER'}, {'name': 'Rumah Sakit Mitra Masyarakat Hospital', 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'University of Sydney', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Nicholas Anstey', 'oldOrganization': 'Menzies School of Health Research'}}}}