Pneumonia Clinical Trial
Official title:
PET Imaging of Endotoxin-induced iNOS Activation in Healthy Volunteers
The overall purpose of this research is to gain understanding of the basic responses of the lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury" involves a generalized inflammation to the lung that is activated by any of several conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to the development of lung inflammation.
Status | Completed |
Enrollment | 19 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Healthy man or woman, any race or ethnicity, age 19 - 44 years old - Screening Pulmonary Function Test - Screening oxygen saturation by pulse oximetry >97% on room air - Capable of lying still and supine within the PET/CT scanner for 1.5 hours - Capable of following instructions for breathing protocol during CT portion of PET/CT - Able and willing to give informed consent - BMI < 35 Exclusion Criteria: - Pregnancy (confirmed by qualitative serum hCG pregnancy test) - Lactation - Active menstruation - History of cardiopulmonary disease - Currently taking any prescription medications - History of tobacco use or illicit drug use within the past year - Presence of implanted electronic medical device - Enrollment in another research study of an investigational drug - Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin - Known allergy to drugs routinely used during bronchoscopy - Inability lie flat for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicne | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Barnes-Jewish Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distribution volume ratio (DVR), determined by Logan plot analysis, in the right middle lobe. | Change in DVR on post-endotoxin scan (Day 2) from baseline (Day 1). | No | |
Secondary | Bronchoalveolar lavage (BAL) fluid cell counts. | Total nucleated and neutrophil cell counts obtained by BAL after endotoxin instillation. | 24 hours after endotoxin instillation. | No |
Secondary | Number and percent of iNOS-stained BAL cells. | 24 hours after endotoxin instillation. | No |
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