Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (230% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00001303 record still lists
NCT00001303 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (230% higher).
The record links to 0 conditions, and to 2 interventions - of which Inhaled Nitric Oxide is the first listed.
NCT00001303 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001303's enrollment target sits among peer trials
198 277th of 2000 higher than 1,723 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05203328 · 198 participants · NA
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
- NCT05426967 · 198 participants · NA
rTMS for Military TBI-related Depression
- NCT05561114 · 198 participants · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
- NCT05585190 · 198 participants · NA
Stand Up for Your Health with a Sit-stand Desk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI