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Sponsors and Collaborators: |
Mahidol University Thailand Research Fund |
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Information provided by: | Mahidol University |
ClinicalTrials.gov Identifier: | NCT00592566 |
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.
Methods: 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.
Condition | Intervention | Phase |
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Leptospirosis |
Drug: Dexamethasone, desmopressin |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis |
Enrollment: | 64 |
Study Start Date: | July 2003 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Standard supportive care
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2: Experimental
Dexamethasone treatment
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Drug: Dexamethasone, desmopressin
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
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3: Experimental
Desmopressin treatment
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Drug: Dexamethasone, desmopressin
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
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Ages Eligible for Study: | 15 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Thailand, Loei Province | |
Loei Hospital | |
Mueng, Loei Province, Thailand, 45000 |
Principal Investigator: | Kanigar Niwattayakul, MD | Loei Hospital, Loei, Thailand: |
Study Chair: | Yupin Suputtamongkol, MD | Mahidol University, Thailand: |
Responsible Party: | Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand ( Prof. Yupin Suputtamongkol ) |
Study ID Numbers: | DDP2003, RDG4630213 |
Study First Received: | January 1, 2008 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00592566 |
Health Authority: | Thailand: Ethical Committee |
Severe leptospirosis Pulmonary hemorrhage |
Arginine Vasopressin Dexamethasone Bacterial Infections Leptospirosis Deamino Arginine Vasopressin |
Vasopressins Weil Disease Hemorrhage Dexamethasone acetate Gram-Negative Bacterial Infections |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Coagulants Antineoplastic Agents Physiological Effects of Drugs Hematologic Agents Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Cardiovascular Agents Hormones |
Glucocorticoids Pharmacologic Actions Hemostatics Spirochaetales Infections Natriuretic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidiuretic Agents Central Nervous System Agents |