Blue Light for Infections

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bright blue light exposure (also known as Blue Light Therapy or Phototherapy) can reduce inflammation and organ problems in patients treated for serious infections. It targets individuals receiving medical care for pneumonia or undergoing surgeries for infections like an infected joint or diverticulitis. Participants will receive either bright blue light or standard white light for three days to determine if the blue light has a beneficial effect. Hospitalized patients with these infections might find this trial suitable. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this blue light therapy is safe for patients with infections?

Research shows that blue light therapy is generally safe and well-tolerated for treating various infections. Studies have found that blue light phototherapy does not harm healthy cells, suggesting safety for infections like MRSA. In cases of pneumonia, blue light has helped clear bacteria and reduce inflammation, indicating a positive safety profile.

For infections like necrotizing soft tissue infections and infected joints, blue light has effectively fought bacteria without causing significant side effects. Reports also show that blue light can reduce inflammation and promote healing without damaging healthy tissues.

In the case of intraabdominal infections, blue light exposure has helped clear bacteria and reduce overall inflammation. These findings suggest that the therapy is not only effective but also safe to use.

Overall, existing research supports that blue light therapy is generally safe and well-tolerated in humans for various infections. However, as with any treatment, individual experiences may vary. It's always important to consider personal health conditions and consult healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about blue light therapy for infections because it offers a non-invasive approach that doesn't rely on traditional antibiotics. This treatment uses bright blue light, peaking at 442 nm, to potentially disrupt bacterial growth and improve infection outcomes. Unlike the standard use of antibiotics for conditions like necrotizing soft tissue infections, infected joints, intra-abdominal infections, and pneumonia, blue light therapy could reduce reliance on medication and help combat antibiotic resistance. Additionally, the treatment is delivered in a controlled light-dark cycle, making it a novel and potentially safer option for patients.

What evidence suggests that blue light therapy could be effective for reducing inflammation in infections?

Research has shown that blue light therapy might help treat infections by reducing harmful bacteria and inflammation. In this trial, participants with different types of infections will receive blue light therapy in separate treatment arms. For severe skin infections, studies have found that blue light can lower bacteria levels and aid in tissue healing. Blue light has improved infected joints by easing pain and swelling. In cases of abdominal infections, animal studies suggest blue light helps clear bacteria and reduces organ damage. Research on pneumonia indicates that blue light can remove bacteria and improve survival rates in test models. These findings suggest that blue light therapy could improve outcomes for various infections by reducing bacteria and inflammation. ^{2 6 7 8 9}

Who Is on the Research Team?

Matthew R Rosengart, MD MPH

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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]

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]

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, 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7358969/

Effect of Blue Light and Photosensitizers on Cutibacterium ... We sought to evaluate the effect of photodynamic therapy using blue light and photosensitizers on C. acnes isolates from shoulder prosthetic joint infections.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8660004/

Blue-light treatment reduces spontaneous and evoked pain ... From all treatments, only BL reduced NRS pain scores significantly (Fig. 3). This effect was visible as early as 10 minutes after initiation of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0753332211000291

Effect of light-emitting diode (LED) therapy on the ... There was general preservation of the articular surface and decreased levels of inflammation in the osteoarthritic joints with the application of LED therapy.

4. nature.com nature.com/articles/s41377-025-01990-z

Challenges and opportunities in next-generation LED ... Yellow light (570 ~ 590 nm) enhances immune function and improves mood, and red light (620 ~ 750 nm) promotes wound healing, hair growth, and ...

5. liebertpub.com liebertpub.com/doi/abs/10.1089/photob.2020.4932

Characterization of Blue Light Treatment for Infected Wounds Conclusions: BL treatment can be effective against bacterial infections of chronic wounds. Nevertheless, using longer wavelengths >455 nm should ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5699711/

Antimicrobial blue light inactivation of pathogenic microbes As an innovative non-antibiotic approach, antimicrobial blue light in the spectrum of 400–470 nm has demonstrated its intrinsic antimicrobial properties.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0169409X22000886

Nanoparticle enhanced blue light therapy Controlled drug release treating bacterial infection with upconversion nanoparticle-mediated blue light therapy ... infection: efficacy, safety, and mechanism of ...

8. biorxiv.org biorxiv.org/content/10.1101/2024.04.13.589323v1.full-text

Antimicrobial blue light-bathing therapy for wound infection ... We discovered that prolonged exposure to 410-nm light at just 5 mW/cm2 can effectively prevent bacterial growth and keep the in vivo wound ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8665112/

Phototherapy and Optical Waveguides for the Treatment of ... This review outlines principles and applications of phototherapy and optical waveguides for infection control.