Search / Trial NCT00001303

Effects of Endotoxin in Normal Human Volunteers

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Nov 3, 1999

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Hemodynamics Lung Permeability Endotoxin Tolerance Bronchoscopy Human Recombinant Interleukin 1 Receptor Normal Volunteer

Description

Endotoxin is a unique molecule because it represents an important probe for investigating the humoral and cellular basis of septic shock. Endotoxin administration to humans provides an opportunity to evaluate the earliest responses that are activated after exposure to an important bacterial component. Many alterations in organ function and circulating mediators can be evaluated in this model. These changes are qualitatively similar to changes that occur during sepsis and septic shock. The applications of new technologies to this model are useful adjuncts to define mechanisms of acute inflam...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • 18 to 45 years of age, either male or female
  • Employees or non-employees are eligible
  • Normal screening examination:
  • history and physical examination, nonsmoker, no concurrent medications including aspirin or nonsteroidal anti-inflammatory drugs, no active medical problems;
  • complete blood count with differential and platelet counts;
  • serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes, prothrombin time, partial thromboplastin time;
  • urinalysis;
  • female subjects must have negative urine pregnancy test within one week of participation;
  • electrocardiogram;
  • chest radiograph.
  • If age is 40 to 45 years, normal submaximal stress test to screen for asymptomatic coronary artery disease.
  • EXCLUSION CRITERIA:
  • Pregnancy.
  • Lactation.
  • History of recent clinically significant asthma.
  • Subjects who have an allergy to both sulfa- and penicillin-based drugs will not be eligible for the endotoxin instillation portion of the study.

Attachments

readout_NCT00001303_2024-06-14.pdf

4.5 MB

NCT00001303_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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