NCT03482245 The Role of Circadian Clock Proteins in Innate and Adaptive Immunity
| NCT ID | NCT03482245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2024-10-29 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Our data suggest that modulating the characteristics of light carries the potential to modify the host response to injury and critical illness and thus, improve outcome. The ability to modify the host response to the stress of major operations and sepsis carries immense potential to improve patient care. The primary purpose of this study is to determine if exposure to bright blue (442nm) enriched light, by comparison to ambient white fluorescent light, reduces the inflammatory response or organ dysfunction in patients undergoing 1) medical treatment for pneumonia, 2) a 2-stage arthroplasty for surgical management of a septic joint, 3) surgery for a necrotizing soft tissue infection (NSTI), and 4) surgery for an intraabdominal infection (e.g., diverticulitis). We will expose participants to one of two (2) lighting conditions: 1) high illuminance (\~1700 lux,), blue (442nm) spectrum enriched light and 2) ambient white fluorescent light that provides the standard environmental lighting (\~300-400 lux, no predominant spectrum) of the hospital. Both cohorts will be exposed to a 12 hours:12 hours light:dark cycle photoperiod. Those subjects assigned to blue light will be asked to shine this small portable blue enriched light on themselves from 0800 to 2000 for 3 days. At the transition from light to dark, the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter. Thus, the total period of intervention is 72 hours. The outcome of interest is change in the inflammatory response after surgery for appendicitis or diverticulitis as measured by the following parameters: white blood cell count, heart rate, the development of abdominal abscess, serum cytokine concentrations. The outcome of interest is change in the inflammatory response during pneumonia as measured by the following parameters: white blood cell count, heart rate, and serum cytokine concentrations.
Eligibility Criteria
Inclusion Criteria: * greater than or equal to 18 years of age and less than or equal to 65 years of age * one of the following diagnoses requiring inpatient hospital care 1. an operation for intraabdominal infection 2. an operation for necrotizing soft tissue infection 3. an operation for an infected joint 4. medical treatment of pneumonia. Exclusion Criteria: * traumatic brain injury * blindness * immunocompromised or immunosuppressed state * infection requiring treatment in preceding 30 days * blindness * SARS-CoV-2
Contact & Investigator
Matthew R Rosengart, MD MPH
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT03482245 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03482245 currently recruiting?
Yes, NCT03482245 is actively recruiting participants. Contact the research team at matthew.r@wustl.edu for enrollment information.
Where is the NCT03482245 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT03482245 clinical trial?
NCT03482245 is sponsored by Washington University School of Medicine. The principal investigator is Matthew R Rosengart, MD MPH at Washington University School of Medicine. The trial plans to enroll 144 participants.