Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-21 @ 4:58 PM
Study NCT ID:
NCT00592566
Status:
TERMINATED
Last Update Posted:
2008-01-14
First Post:
2008-01-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007922', 'term': 'Leptospirosis'}], 'ancestors': [{'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Numbe of eligible patients has been decreased over time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-11', 'studyFirstSubmitDate': '2008-01-01', 'studyFirstSubmitQcDate': '2008-01-11', 'lastUpdatePostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'during in hospital admission'}], 'secondaryOutcomes': [{'measure': 'Days of mechanical ventilation', 'timeFrame': 'during hospital admission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Severe leptospirosis', 'Pulmonary hemorrhage'], 'conditions': ['Leptospirosis']}, 'descriptionModule': {'briefSummary': 'Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand.\n\nMethods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (\\> 14 years) with suspected severe leptospirosis\n* patients who presented with acute fever (oral temperature more than 38.00 C for \\<15 days) in the absence of an obvious focus of infection\n* In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).\n\nExclusion Criteria:\n\n* pregnant or breastfeeding\n* those with history of bleeding disorder\n* those who had underlying diseases such as chronic liver disease, diabetes mellitus\n* those who received diuretic or glucocorticoid'}, 'identificationModule': {'nctId': 'NCT00592566', 'briefTitle': 'Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis', 'orgStudyIdInfo': {'id': 'DDP2003'}, 'secondaryIdInfos': [{'id': 'RDG4630213'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Standard supportive care'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Dexamethasone treatment', 'interventionNames': ['Drug: Dexamethasone, desmopressin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Desmopressin treatment', 'interventionNames': ['Drug: Dexamethasone, desmopressin']}], 'interventions': [{'name': 'Dexamethasone, desmopressin', 'type': 'DRUG', 'otherNames': ['Minirin'], 'description': '200 mg of dexamethasone IV infusion OD for 3 days or 0.3 microgram/ kg of desmopressin in 50 ml of saline, as a 30- minute infusion', 'armGroupLabels': ['2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45000', 'city': 'Mueng', 'state': 'Changwat Loei', 'country': 'Thailand', 'facility': 'Loei Hospital'}], 'overallOfficials': [{'name': 'Kanigar Niwattayakul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loei Hospital, Loei, Thailand:'}, {'name': 'Yupin Suputtamongkol, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thailand Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Yupin Suputtamongkol', 'oldOrganization': 'Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand'}}}}