Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

Mahidol University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Leptospirosis

Treatments: Drug: Dexamethasone, desmopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT00592566

DDP2003

RDG4630213

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 15 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

1

No Intervention group

Description:

Standard supportive care

2

Experimental group

Description:

Dexamethasone treatment

Treatment:

Drug: Dexamethasone, desmopressin

3

Experimental group

Description:

Desmopressin treatment

Treatment:

Drug: Dexamethasone, desmopressin