Inflammation and the Host Response to Injury (In Healthy Volunteers)

Immune System Clinical Trial

— Mono  

Official title:

Inflammation and the Host Response to Injury (In Healthy Volunteers)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820989
• Other study ID #: 0220013432
• Secondary ID: GM64351-01
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2009
• Last updated: May 20, 2014
• Start date: February 2000
• Est. completion date: February 2011

Study information

• Verified date: May 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.

Description:

The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's "instructions" for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study.

• Written informed consent prior to the performance of any study related procedure.

Exclusion Criteria:

• History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension

• Recent history of alcohol or drug abuse

• Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures

• Exposure to any experimental agent or procedure within 30 days of study

• Pregnancy or breast feeding

• Prior exposure to endotoxin in an experimental setting -

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Immune System

Intervention

Biological:
• Endotoxin, Lipopolysaccharide, LPS
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)

Locations

Country	Name	City	State
United States	Rutgers-RWJMS	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological, Hematological, Immunological Responses		.5-24 hours after Endotoxin administration	No