Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis - Full Text View

Sponsor:	Mahidol University
Collaborator:	Thailand Research Fund
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00592566

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 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

Resource links provided by NLM:

Drug Information available for: Dexamethasone Desmopressin Dexamethasone acetate Desmopressin acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Survival [ Time Frame: during in hospital admission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Days of mechanical ventilation [ Time Frame: during hospital admission ] [ Designated as safety issue: No ]

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
1: No Intervention Standard supportive care
2: Experimental 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
3: Experimental 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

Eligibility

Ages Eligible for Study:	15 Years to 90 Years
Genders Eligible for Study:	Both
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

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

Locations

Thailand, Loei Province
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, Thailand:

More Information

No publications provided

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 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Severe leptospirosis
Pulmonary hemorrhage

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Bacterial Infections
Coagulants
Antineoplastic Agents
Physiological Effects of Drugs
Hematologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Gram-Negative Bacterial Infections
Therapeutic Uses
Dexamethasone acetate
Antineoplastic Agents, Hormonal

Leptospirosis
Gastrointestinal Agents
Weil Disease
Cardiovascular Agents
Glucocorticoids
Hemostatics
Pharmacologic Actions
Natriuretic Agents
Spirochaetales Infections
Autonomic Agents
Deamino Arginine Vasopressin
Peripheral Nervous System Agents
Antidiuretic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009