Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis - Tabular View

Tracking Information

First Received Date ^ICMJE

January 1, 2008

Last Updated Date

January 11, 2008

Start Date ^ICMJE

July 2003

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Survival [ Time Frame: during in hospital admission ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00592566 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Days of mechanical ventilation [ Time Frame: during hospital admission ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Leptospirosis

Intervention ^ICMJE

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

Other Name: Minirin

Study Arms / Comparison Groups

1: No Intervention
Standard supportive care
2: Experimental
Dexamethasone treatment

Intervention: Drug: Dexamethasone, desmopressin
3: Experimental
Desmopressin treatment

Intervention: Drug: Dexamethasone, desmopressin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00592566

Responsible Party

Prof. Yupin Suputtamongkol, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

Study ID Numbers ^ICMJE

DDP2003, RDG4630213

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Thailand Research Fund

Investigators ^ICMJE

Principal Investigator:	Kanigar Niwattayakul, MD	Loei Hospital, Loei, Thailand:
Study Chair:	Yupin Suputtamongkol, MD	Mahidol University, Thailand:

Information Provided By

Mahidol University

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP