Clinical trial NCT05090657: Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures
Official title: Bacterial Eradication of the Nasal Epithelium From Infectious Toxins With PDT (BENEFIT-PDT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Site Infections
Nosocomial Infection
Healthcare Associated Infections
Keywords: Staphylococcus aureus
Photodynamic therapy
Photodisinfection
Methylene blue
Nasal decolonization
Surgical infections
Lead sponsor: Ondine Biomedical Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The sample size will be one month of all surgical cases and is estimated at 500-600 cases. Both genders and a wide range of ages and medical conditions will be represented from all ethnic/demographic groups and of varying health status.
Primary purpose: PREVENTION

Brief summary: This is a Phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (aPDT) for nasal disinfection in all patients (universal) presenting for surgery at an acute care hospital for a wide range of surgical procedures.

Detailed description: The purpose of the proposed study is to gather data regarding the safety and efficacy of nasal photodisinfection treatment in eliminating colonization of the anterior nares with S. aureus. The anterior nares are often considered the primary reservoir of S. aureus and other pathogens on the body, therefore, this product could play an important role in helping to eliminate this pathogen reservoir in patients. Since photodisinfection is a non-antibiotic approach that does not generate antibiotic resistance, this could be a beneficial approach to achieving nasal disinfection. Additionally, photodisinfection has an extremely broad spectrum of activity and is effective against bacterial, viral, and fungal pathogens including emerging pathogens such as C. auris.

This is a Phase 2 study. Nasal cultures will be performed on all patients admitted for surgery at Memorial Health University Medical Center over a 1-month period. This will determine the prevalence rate of S. aureus and other pathogens in community patients who are being admitted for surgery. The results of this culture will not be known to the research staff until several days later. Clinical trial subjects will universally receive a nasal disinfection treatment followed by a post-treatment culture. This will demonstrate the efficacy of nasal disinfection against Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form within 30 days of surgery.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female ≥ 18 years of age.
4. Patient being admitted for a surgical procedure.
5. Ability to tolerate a 4-minute non-painful nasal light illumination.

Exclusion Criteria:

1. Male or female \<18 years of age.
2. Inability to tolerate insertion of the nasal light illuminator due to nares size, shape, or anatomical variants.
3. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
4. Nasal obstructions precluding placement of light illuminator.

Primary outcomes:
measure: Microbiological efficacy
timeFrame: Within 1 hour of start of surgery
measure: Side effects of nasal photodisinfection
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of surgical site infections
timeFrame: 30 days
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Memorial University Medical Center
state: Georgia
Study officials:
affiliation: Memorial University Medical Center, Savannah, GA
name: Stephen A. Thacker, MD
role: PRINCIPAL_INVESTIGATOR
References: