Blue Light for Infections

Recruiting at 1 trial location

Overseen By Xianghong Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Traumatic brain injury, Blindness, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

144 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Blue Light Therapy for infections?

Research shows that blue light therapy can effectively kill a wide range of bacteria and fungi, including those resistant to drugs, by using specific wavelengths of light. It has been used successfully for acne and stomach infections, and studies suggest it could help treat wound infections by reducing bacteria and promoting healing. ^{1 2 3 4 5}

Is blue light therapy safe for humans?

Blue light therapy is generally considered safe for humans, but some studies suggest that shorter wavelengths (like 420 nm) can cause skin cell damage at high doses. Longer wavelengths (above 455 nm) are less likely to be toxic to skin cells. ^{1 2 6 7 8}

How is Blue Light Therapy different from other treatments for infections?

Blue Light Therapy is unique because it uses specific wavelengths of light to kill bacteria without the need for antibiotics, making it effective against both drug-sensitive and drug-resistant bacteria. It is less harmful to human cells compared to ultraviolet light and can target bacteria in both their free-floating and biofilm states, which are common in infections. ^{1 2 3 5 9}

Research Team

Matthew R Rosengart, MD MPH

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 who are undergoing surgery for appendicitis or diverticulitis, or receiving treatment for pneumonia. It's not suitable for individuals with traumatic brain injury, blindness, or those who have weakened immune systems.

Inclusion Criteria

I am 18 or older and having surgery for appendicitis, diverticulitis, or being treated for pneumonia.

Exclusion Criteria

You have had a severe head injury, are blind, or have a weakened immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants are exposed to either blue light or ambient white light for 3 days following diagnosis or surgery

1 week

Daily monitoring during hospital stay

Follow-up

Participants are monitored for changes in inflammatory response and organ dysfunction

4 weeks

Weekly follow-up visits

Long-term Follow-up

Participants are monitored for long-term outcomes such as organ dysfunction and need for mechanical ventilation

28 days

Treatment Details

Interventions

• Blue Light

Trial Overview The study tests the effects of blue light exposure on patients' inflammatory responses after surgeries like appendectomy and colon resection, and during pneumonia treatment. The control group doesn't receive blue light to compare outcomes.

Participant Groups

Group I: Pneumonia: Blue Light Experimental Treatment 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.

Group II: Necrotizing Soft Tissue Infection: Blue Light Experimental Treatment 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.

Group III: Intraabdominal infection: Blue Light Experimental Treatment 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.

Group IV: Infected Joint: Blue Light Experimental Treatment 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of bright (1700 lux) blue (peak 442 nm) enriched light for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the blue-enriched light is turned off, and additional blue wavelength light removed with an amber filter.

Group V: Necrotizing Soft Tissue Infection: Ambient Light Active Control 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.

Group VI: Intraabdominal infection: Ambient Light Active Control 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.

Group VII: Infected Joint: Ambient Light Active Control 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.

Group VIII: Pneumonia: Ambient Light Active Control 1 Intervention

a 12 hours:12 hours light:dark photoperiod cycle of the standard white fluorescent ambient light of the hospital for a total of 3 days after the initial diagnosis and informed consent. The photoperiod is 12 hours: 0800 to 2000. At the transition from light to dark (2000), the ambient white lights are turned off.

Blue Light is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Bright Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Jet lag
• Sleep disorders

Approved in United States as Blue Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Circadian rhythm disorders

Approved in Canada as Phototherapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Sleep disorders

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Findings from Research

Pulsed blue light at 405 nm was found to be more effective than continuous wave light in killing E. coli bacteria, indicating a potential improvement in antimicrobial blue light therapy.

The enhanced antimicrobial effect of pulsed light is likely due to increased production of reactive oxygen species (ROS), which causes greater damage to the bacterial cell membrane.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoinactivation of Escherichia coli by 405 nm and 450 nm light-emitting diodes: Comparison of continuous wave and pulsed light. Huang, S., Qin, H., Liu, M.[2023]

A multicenter in vitro study demonstrated that 400-nm blue light effectively inactivates a wide range of bacteria, including both drug-sensitive and drug-resistant strains, with 71% of planktonic bacteria showing a significant decrease in viability after just 15 to 30 minutes of exposure.

Blue light was also effective against bacterial biofilms, which are often resistant to conventional treatments, indicating its potential as a novel decontamination strategy in clinical settings, particularly for wound infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibacterial Activity of Blue Light against Nosocomial Wound Pathogens Growing Planktonically and as Mature Biofilms. Halstead, FD., Thwaite, JE., Burt, R., et al.[2022]

Antibacterial blue light (BL) treatment effectively reduces Pseudomonas aeruginosa in burn wound infections, achieving over 5 log10 CFU/mL reduction with specific treatment parameters (2 hours at 40 mW/cm2).

Higher irradiances and longer treatment times are necessary for significant antibacterial effects, which may complicate integration into standard clinical practices, highlighting the need for further research on its application in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phototherapy of Pseudomonas aeruginosa-Infected Wounds: Preclinical Evaluation of Antimicrobial Blue Light (450-460 nm) Using In Vitro Assays and a Human Wound Skin Model. Leder, MD., Bagheri, M., Plattfaut, I., et al.[2022]

Irradiation with 460 nm blue light (BL) effectively eradicated Candida albicans in both laboratory settings and in infected skin wounds in mice, showing a dose-dependent response with complete eradication at 240 J/cm2.

The study demonstrated that BL not only eliminated C. albicans cells but also significantly promoted wound healing in infected skin, suggesting its potential as a novel treatment for fungal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of 460 nm visible light for the elimination of Candida albicans in vitro and in vivo. Wang, C., Yang, Z., Peng, Y., et al.[2018]

Blue light, especially in the 405-470 nm range, has a strong antimicrobial effect against various bacteria, including those responsible for acne and stomach infections, without harming mammalian cells as much as ultraviolet light does.

The mechanism of action involves the photo-excitation of intracellular porphyrins, leading to the production of harmful reactive oxygen species that kill bacteria, although more research is needed to confirm its effects on wound pathogens and to optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue light for infectious diseases: Propionibacterium acnes, Helicobacter pylori, and beyond? Dai, T., Gupta, A., Murray, CK., et al.[2022]

Antimicrobial blue light (aBL) therapy is an effective non-antibiotic treatment that generates reactive oxygen species to combat various microbial pathogens, as supported by numerous studies over the past six years.

Variability in aBL parameters, such as wavelength and dose, leads to differences in antimicrobial effectiveness, highlighting the need for standardized treatment protocols for clinical and industrial applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Parameters Affecting Antimicrobial Efficiency of Antimicrobial Blue Light Therapy: A Review and Prospect. Huang, S., Lin, S., Qin, H., et al.[2023]

Blue light (BL) treatment, particularly at 420 and 455 nm, effectively reduces bacterial counts in chronic wound infections, especially against Pseudomonas aeruginosa, achieving over 99% reduction in biofilm at 420 nm.

While BL can be effective against wound pathogens, longer wavelengths (above 455 nm) are recommended to minimize potential toxicity to human skin cells, as higher doses of 420 nm light showed significant cell toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Blue Light Treatment for Infected Wounds: Antibacterial Efficacy of 420, 455, and 480 nm Light-Emitting Diode Arrays Against Common Skin Pathogens Versus Blue Light-Induced Skin Cell Toxicity. Plattfaut, I., Demir, E., Fuchs, PC., et al.[2021]

In a study involving 8 healthy volunteers, exposure to visible blue light over five consecutive days did not cause DNA damage or early signs of skin aging, indicating its safety for dermatological use.

The treatment resulted in transient melanogenesis, evidenced by a significant increase in Melan-A-positive cells, and caused vacuolization of keratinocytes, but did not lead to any inflammatory responses or apoptosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and histological effects of blue light on normal skin. Kleinpenning, MM., Smits, T., Frunt, MH., et al.[2010]

Blue light irradiation (BLI) at a wavelength of 455 nm can slow down the growth of Escherichia coli, but it is not effective at killing the bacteria, indicating its role as a growth-retardant rather than a bactericidal treatment.

The effectiveness of BLI varies depending on the bacterial growth phase and the specific strain of E. coli, which is important to consider since bacteria in the human body exist in different growth stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of blue light irradiation effects on pathogenic and nonpathogenic Escherichia coli. Abana, CM., Brannon, JR., Ebbott, RA., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Photoinactivation of Escherichia coli by 405 nm and 450 nm light-emitting diodes: Comparison of continuous wave and pulsed light. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Antibacterial Activity of Blue Light against Nosocomial Wound Pathogens Growing Planktonically and as Mature Biofilms. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Phototherapy of Pseudomonas aeruginosa-Infected Wounds: Preclinical Evaluation of Antimicrobial Blue Light (450-460 nm) Using In Vitro Assays and a Human Wound Skin Model. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Application of 460 nm visible light for the elimination of Candida albicans in vitro and in vivo. [2018]

5. Scotland pubmed.ncbi.nlm.nih.gov

Blue light for infectious diseases: Propionibacterium acnes, Helicobacter pylori, and beyond? [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Parameters Affecting Antimicrobial Efficiency of Antimicrobial Blue Light Therapy: A Review and Prospect. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Characterization of Blue Light Treatment for Infected Wounds: Antibacterial Efficacy of 420, 455, and 480 nm Light-Emitting Diode Arrays Against Common Skin Pathogens Versus Blue Light-Induced Skin Cell Toxicity. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Clinical and histological effects of blue light on normal skin. [2010]

9. England pubmed.ncbi.nlm.nih.gov

Characterization of blue light irradiation effects on pathogenic and nonpathogenic Escherichia coli. [2021]