NCT00592566

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
Last Updated

January 14, 2008

Status Verified

December 1, 2007

Enrollment Period

3.3 years

First QC Date

January 1, 2008

Last Update Submit

January 11, 2008

Conditions

Leptospirosis

Keywords

Severe leptospirosisPulmonary hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Survival

    during in hospital admission

Secondary Outcomes (1)

  • Days of mechanical ventilation

    during hospital admission

Study Arms (3)

1

NO INTERVENTION

Standard supportive care

2

EXPERIMENTAL

Dexamethasone treatment

Drug: Dexamethasone, desmopressin

3

EXPERIMENTAL

Desmopressin treatment

Drug: Dexamethasone, desmopressin

Interventions

Dexamethasone, desmopressinDRUG

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

Also known as: Minirin
23

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loei Hospital

Mueng, Changwat Loei, 45000, Thailand

Location

MeSH Terms

Conditions

Leptospirosis

Interventions

DexamethasoneDeamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Spirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedArginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Kanigar Niwattayakul, MD

    Loei Hospital, Loei, Thailand:

    PRINCIPAL INVESTIGATOR

  • Yupin Suputtamongkol, MD

    Mahidol University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 1, 2008

First Posted

January 14, 2008

Study Start

July 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

January 14, 2008

Record last verified: 2007-12

Locations

TH(1)