Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

• Status: Terminated
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: Thailand Research Fund
• Treatments: BB 1101; Deamino Arginine Vasopressin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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