Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

January 11, 2008 updated by: Mahidol University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Loei Province
      • Mueng, Loei Province, Thailand, 45000
        • Loei Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 88 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Standard supportive care
Experimental: 2
Dexamethasone treatment
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 Names:
  • Minirin
Experimental: 3
Desmopressin treatment
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 Names:
  • Minirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: during in hospital admission
during in hospital admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Days of mechanical ventilation
Time Frame: during hospital admission
during hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Thailand Research Fund

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

January 1, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Estimate)

January 14, 2008

Last Update Submitted That Met QC Criteria

January 11, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDP2003
  • RDG4630213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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