Desmopressin and Dexamethasone Adjunctive Treatment for L... | NCT00592566

Studies
Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

NCT00592566

Sponsor

Mahidol University

Status

Terminated

Last Update Posted

Jan 14, 2008Estimated

Enrollment

64Actual

Phase

Phase 2Phase 3

Conditions

Leptospirosis

Interventions

Dexamethasone, desmopressin

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RDG4630213

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Numbe of eligible patients has been decreased over time.

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Jan 1, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2008

Last Update Posted Date

Jan 14, 2008Estimated

Name	Class
Thailand Research Fund	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Standard supportive care
2	Experimental	Dexamethasone treatment	Drug: Dexamethasone, desmopressin
3	Experimental	Desmopressin treatment	Drug: Dexamethasone, desmopressin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone, desmopressin	Drug	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	2

Measure	Description	Time Frame
Survival		during in hospital admission

Measure	Description	Time Frame
Days of mechanical ventilation		during hospital admission

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loei Hospital		Mueng	Changwat Loei	45000	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D007922	Leptospirosis

Ancestor Terms

ID	Term
D013145	Spirochaetales Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D003894	Deamino Arginine Vasopressin

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided