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Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

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ClinicalTrials.gov Identifier: NCT00592566
Recruitment Status : Terminated (Numbe of eligible patients has been decreased over time.)
First Posted : January 14, 2008
Last Update Posted : January 14, 2008
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by:
Mahidol University

Tracking Information
First Submitted Date  ICMJE January 1, 2008
First Posted Date  ICMJE January 14, 2008
Last Update Posted Date January 14, 2008
Study Start Date  ICMJE July 2003
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
Survival [ Time Frame: during in hospital admission ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
Days of mechanical ventilation [ Time Frame: during hospital admission ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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  ICMJE
  • No Intervention: 1
    Standard supportive care
  • Experimental: 2
    Dexamethasone treatment
    Intervention: Drug: Dexamethasone, desmopressin
  • Experimental: 3
    Desmopressin treatment
    Intervention: Drug: Dexamethasone, desmopressin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 11, 2008)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00592566
Other Study ID Numbers  ICMJE DDP2003
RDG4630213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Yupin Suputtamongkol, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
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
PRS Account Mahidol University
Verification Date December 2007

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