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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00592566
Other study ID # DDP2003
Secondary ID RDG4630213
Status Terminated
Phase Phase 2/Phase 3
First received January 1, 2008
Last updated January 11, 2008
Start date July 2003
Est. completion date October 2006

Study information

Verified date December 2007
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 64
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Thailand Loei Hospital Mueng Loei Province

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival during in hospital admission Yes
Secondary Days of mechanical ventilation during hospital admission No
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