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NCT00001303 · ClinicalTrials.gov registry record · Phase 1
Effects of Endotoxin in Normal Human Volunteers
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 198
- Enrollment target
NCT00001303 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 198 participants.
The verdict
NCT00001303, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 198 participants
- Enrollment target
Study Summary
Bacterial infections can progress to a life-threatening illness called septic shock, characterized by low blood pressure and vital organ damage. The syndrome is thought to be caused by parts of the bacteria and by the body s own immune response to the infection. A major bacterial product that interacts with the immune defenses is called endotoxin. This study will examine the body s response to endotoxin in the lungs or bloodstream. When endotoxin is given in small amounts to humans, even though it is not an infection, it triggers a set of responses that are typical of what one would see with a true bacterial infection. This allows us to study the earliest changes in molecules and cells that are involved in some bacterial infections. This type of model is safe and has been used in humans for many years to understand the body s responses during infections. Normal volunteers 18 to 45 years of age may be eligible for this study. Candidates will have a history and physical examination, blood and urine tests, electrocardiogram (EKG) and chest X-ray. In addition, volunteers 40 to 45 years old will have an exercise stress test to screen for asymptomatic coronary artery disease. Participants will undergo one or more of the following procedures: Bronchoscopy, Bronchoalveolar Lavage, Bronchial Brushings, and Endobronchial Mucosal Biopsies: These techniques for examining lung function are used routinely in patient care and clinical research. The mouth and nasal and lung airways are numbed with an anesthetic. A bronchoscope (pencil-thin flexible tube) is then passed through the nose into the large airways of the lung. Cells and secretions from the airways are rinsed with salt water (bronchoalveolar lavage) and a flexible brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways. Lastly, pieces of tissue (the size of the ball of a ballpoint pen) lining the airways are removed for examination under the microscope. Intravenous Endotoxin
Interventions
- DRUG Inhaled Nitric Oxide
- DRUG Reference Endotoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 1992-04-06 |
| Est. Completion | 2018-05-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001303
The ClinicalTrials.gov registry entry for NCT00001303 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Inhaled Nitric Oxide is the first listed.
NCT00001303 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001303 about?
NCT00001303 is a clinical study titled "Effects of Endotoxin in Normal Human Volunteers". Bacterial infections can progress to a life-threatening illness called septic shock, characterized by low blood pressure and vital organ damage. The syndrome is thought to be caused by parts of the bacteria and by the body s own immune response to the infection. A major bacterial product that intera...
What is the current status of trial NCT00001303?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 198 participants. The study started on 1992-04-06. Estimated completion is 2018-05-17.
What interventions are being tested in trial NCT00001303?
The interventions under investigation include: Inhaled Nitric Oxide (DRUG), Reference Endotoxin (DRUG).
Who is sponsoring clinical trial NCT00001303?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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