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NCT03482245 · ClinicalTrials.gov registry record · NA

The Role of Circadian Clock Proteins in Innate and Adaptive Immunity

A NA study of Pneumonia and Necrotizing Soft Tissue Infection, sponsored by Washington University School of Medicine.

Recruiting
Registry status
NA
Development phase
144
Enrollment target
1
Study location

NCT03482245 is a NA study of Pneumonia and Necrotizing Soft Tissue Infection that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 144 participants, below the 4,516-participant average among 47 other Pneumonia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03482245, a NA study of Pneumonia and Necrotizing Soft Tissue Infection, is actively recruiting participants, sponsored by Washington University School of Medicine.

RECRUITING
Registry status
NA
Development phase
144 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • OTHER Blue Light

Study Locations (1)

Missouri

  • Barnes Jewish Hospital - St Louis

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2024-10-29
Est. Completion 2026-12-31
Phase NA

What the Registry Record Tells You About NCT03482245

The ClinicalTrials.gov registry entry for NCT03482245 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,516-participant average among 47 other Pneumonia trials with a reported enrollment target (97% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Pneumonia appearing as the primary indexed condition, and to 1 intervention - of which Blue Light is the first listed.

NCT03482245 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT03482245 about?

NCT03482245 is a clinical study titled "The Role of Circadian Clock Proteins in Innate and Adaptive Immunity". 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 ...

What is the current status of trial NCT03482245?

This trial is currently recruiting. It is a NA study. The enrollment target is 144 participants. The study started on 2024-10-29. Estimated completion is 2026-12-31.

What conditions does trial NCT03482245 study?

This clinical trial studies the following conditions: Pneumonia, Necrotizing Soft Tissue Infection, Intraabdominal Infections, Infection Joint.

What interventions are being tested in trial NCT03482245?

The interventions under investigation include: Blue Light (OTHER).

Who is sponsoring clinical trial NCT03482245?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03482245 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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