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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
Endpoint Classification: Safety/Efficacy Study
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:

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
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
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 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: 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
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Severe leptospirosis
Pulmonary hemorrhage

Additional relevant MeSH terms:
Leptospirosis
Weil Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Deamino Arginine Vasopressin
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
 Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013