Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

Leptospirosis Clinical Trial

Official title:

An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00592566
• Other study ID #: DDP2003
• Secondary ID: RDG4630213
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: January 1, 2008
• Last updated: January 11, 2008
• Start date: July 2003
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leptospirosis

Intervention

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

Locations

Country	Name	City	State
Thailand	Loei Hospital	Mueng	Loei Province

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		during in hospital admission	Yes
Secondary	Days of mechanical ventilation		during hospital admission	No