Trial record 1 of 6 for: "Leptospirosis"

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Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

This study has been terminated.

(Numbe of eligible patients has been decreased over time.)

Sponsor:

Collaborator:

Thailand Research Fund

Information provided by:

Mahidol University

ClinicalTrials.gov Identifier:

NCT00592566

First received: January 1, 2008

Last updated: January 11, 2008

Last verified: December 2007

History of Changes

Purpose

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
Leptospirosis	Drug: Dexamethasone, desmopressin	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis

Resource links provided by NLM:

MedlinePlus related topics: Bleeding

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Desmopressin Dexamethasone acetate Desmopressin acetate

Genetic and Rare Diseases Information Center resources: Leptospirosis

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Survival [ Time Frame: during in hospital admission ]

Secondary Outcome Measures:

Days of mechanical ventilation [ Time Frame: during hospital admission ]


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
No Intervention: 1 Standard supportive care
Experimental: 2 Dexamethasone treatment	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 Other Name: Minirin
Experimental: 3 Desmopressin treatment	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 Other Name: Minirin

Eligibility


Ages Eligible for Study:	15 Years to 90 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients (> 14 years) with suspected severe leptospirosis
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
In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).

Exclusion Criteria:

pregnant or breastfeeding
those with history of bleeding disorder
those who had underlying diseases such as chronic liver disease, diabetes mellitus
those who received diuretic or glucocorticoid

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592566

Locations


Thailand
Loei Hospital
Mueng, Loei Province, Thailand, 45000

Sponsors and Collaborators

Mahidol University

Thailand Research Fund

Investigators


Principal Investigator:	Kanigar Niwattayakul, MD	Loei Hospital, Loei, Thailand:
Study Chair:	Yupin Suputtamongkol, MD	Mahidol University

More Information


Responsible Party:	Prof. Yupin Suputtamongkol, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
ClinicalTrials.gov Identifier:	NCT00592566 History of Changes
Other Study ID Numbers:	DDP2003 RDG4630213
Study First Received:	January 1, 2008
Last Updated:	January 11, 2008

Keywords provided by Mahidol University:


Severe leptospirosis Pulmonary hemorrhage

Additional relevant MeSH terms:


Leptospirosis Weil Disease Gram-Negative Bacterial Infections Bacterial Infections Spirochaetales Infections Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Deamino Arginine Vasopressin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Antidiuretic Agents Natriuretic Agents

ClinicalTrials.gov processed this record on July 14, 2017

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