Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

This study has been terminated.
(Numbe of eligible patients has been decreased over time.)
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00592566
First received: January 1, 2008
Last updated: January 11, 2008
Last verified: December 2007

January 1, 2008
January 11, 2008
July 2003
October 2006   (final data collection date for primary outcome measure)
Survival [ Time Frame: during in hospital admission ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00592566 on ClinicalTrials.gov Archive Site
Days of mechanical ventilation [ Time Frame: during hospital admission ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leptospirosis
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
  • No Intervention: 1
    Standard supportive care
  • Experimental: 2
    Dexamethasone treatment
    Intervention: Drug: Dexamethasone, desmopressin
  • Experimental: 3
    Desmopressin treatment
    Intervention: Drug: Dexamethasone, desmopressin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
15 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00592566
DDP2003, RDG4630213
No
Prof. Yupin Suputtamongkol, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Mahidol University
Thailand Research Fund
Principal Investigator: Kanigar Niwattayakul, MD Loei Hospital, Loei, Thailand:
Study Chair: Yupin Suputtamongkol, MD Mahidol University, Thailand:
Mahidol University
December 2007

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