Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Leptospirosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard supportive care

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Dexamethasone treatment

Group Type EXPERIMENTAL

Dexamethasone, desmopressin

Intervention Type DRUG

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

Desmopressin treatment

Group Type EXPERIMENTAL

Dexamethasone, desmopressin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Minirin

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No