NCT00197899

Brief Summary

The purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

December 13, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

December 12, 2005

Conditions

EndotoxemiaSepsis

Interventions

E. Coli endotoxinDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Infection 14 days prior to the trial Regular medication Present and /or former heart disease -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care

Copenhagen, Copenhagen County, 2730, Denmark

Location

MeSH Terms

Conditions

EndotoxemiaSepsis

Interventions

endotoxin, Escherichia coli

Condition Hierarchy (Ancestors)

BacteremiaInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bente K Pedersen, MD, DMSc

    Department of Infectious Diseases 7641, University Hospital of Copenhagen, H:S Rigshospitalet

    STUDY CHAIR

  • Dorthe H Olsen, MD

    Department of Intensive Care, Herlev University Hospital

    PRINCIPAL INVESTIGATOR

  • Dorthe H Olsen, DM

    Department of Intensive Care, Herlev University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

March 1, 2004

Study Completion

January 1, 2005

Last Updated

December 13, 2005

Record last verified: 2005-09

Locations

DK(1)