Photodisinfection for the Decolonization of Staphylococcus Aureus in Hemodialysis Patients

McMaster University

Status

Withdrawn

Conditions

Staphylococcus Aureus Infection

MSSA Colonization

Treatments

Device: photodynamic therapy (Ondine: MRSAid™)

Study type

Interventional

Funder types

Other

Identifiers

NCT02741869

HD.SA-1

Details and patient eligibility

About

The purpose of the study is to evaluate whether PDT (MRSAid™) is effective in eradicating SA from hemodialysis patients who are known to harbor this organism inside their nose.

Full description

This is a medical research study is to eliminate Staphylococcus aureus (SA) (decolonization) from nares of patients who are colonized with this organism. Bacterial colonization of the anterior nares (inside of the nose) is believed to play an important role in the development of infection of central venous catheter, such as the line used for hemodialysis, and subsequent bloodstream infection.

Photodynamic therapy (PDT) has been shown to be lethal against all classes of microorganisms: Gram-positive and, Gram-negative bacteria, fungi (fungus), viruses, parasites and even spores. In addition to the antimicrobial effects PDT also demonstrates an anti-inflammatory effect.

The objective of this study is to evaluate the efficacy of PDT in nasal decolonization of S. aureus in hemodialysis patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is able to provide written informed consent. (If the patient is unable to provide written informed consent, the patient's legally accepted representative may provide written consent as approved by institution-specific guidelines)
Age ≥ 18
Currently undergoing hemodialysis and has hemodialysis catheter in-situ
Positive SA culture from anterior nare within 2 weeks of enrollment.
Have had no antibacterial therapy for any reason within the previous 7 days
Patient is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study

Exclusion criteria

Patient has taken antibiotics in the last 7 days
Patient has taken an investigational medication in the last 30 days or is involved in a clinical study
Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control (e.g., condom, hormonal contraceptive, indwelling intrauterine device, sexual abstinence)
Patient uses nasal medication that cannot be discontinued on the day of scheduled photodisinfection therapy.
Patient is on oxygen via nasal cannula
Patient has an active malignancy of any type by patient report, except for basal cell carcinoma
Patient's surgery involves the nasal or oral cavity (e.g. repair of deviated septum)
Patient has had surgery of the nasal tract or sinuses within the prior 3 months
Patient has a history of moderate to severe hypersensitivity reactions to methylene blue (mild rash is not a contraindication to enrollment)
Patient has active ulcerations of the nasal septum
Patient has nasal polyps
Patient has suspected or confirmed rhinosinusitis as evidenced by all three of the following:
Sneezing
Nasal congestion or rhinorrhea
Patient has suspected or confirmed sinusitis
Patient has suspected or confirmed upper respiratory infection as evidenced by at least one of the following symptoms:
Fever of up to 38 oC.
Sore throat, laryngitis
Post-nasal mucus, cough
Patient has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure and septic shock
Patient has an immunocompromising illness including known infection with human immunodeficiency virus (HIV), AIDS, hematological malignancy and bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, imuran and the administration of corticosteroids equivalent to or greater than 40 mg of prednisone per day administered for more than 14 days
Patient is anticipated to receive any amount of potentially therapeutic antimicrobial therapy after collection of the pretreatment baseline culture and before administration of the study treatment
Patient has a current urinary catheter that will not be removed or anticipation of urinary catheter placement that will not be removed during the course of study treatment. (Clarification: Intermittent straight catheterization after the study treatment is acceptable.)
Patient has a concomitant infection requiring systemic antibiotic or antifungals at the time of assignment of patient number
Patient has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study