Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis
Information source: Mahidol University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leptospirosis
Intervention: Dexamethasone, desmopressin (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Kanigar Niwattayakul, MD, Principal Investigator, Affiliation: Loei Hospital, Loei, Thailand:
Yupin Suputtamongkol, MD, Study Chair, Affiliation: Mahidol University, Thailand:
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.
Clinical Details
Official title: An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Survival
Secondary outcome: Days of mechanical ventilation
Eligibility
Minimum age: 15 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Loei Hospital, Mueng, Loei Province 45000, Thailand
Additional Information
Starting date: July 2003
Ending date: October 2006
Last updated: January 11, 2008
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