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Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

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

Status
Terminated
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00592566
Enrollment
64
Registered
2008-01-14
Start date
2003-07-31
Completion date
2006-10-31
Last updated
2008-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptospirosis

Keywords

Severe leptospirosis, Pulmonary hemorrhage

Brief 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.

Interventions

DRUGDexamethasone, 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

Sponsors

Thailand Research Fund
CollaboratorOTHER
Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Survivalduring in hospital admission

Secondary

MeasureTime frame
Days of mechanical ventilationduring hospital admission

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026