Photodisinfection for the Decolonization of Staphylococcus Aureus in Hemodialysis Patients

NCT02741869 | Withdrawn

• 1 other identifier: HD.SA-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Staphylococcus Aureus Infection; MSSA Colonization

Keywords

Staphylococcus aureus; nare carriage

Outcome Measures

Primary Outcomes (1)

• The efficacy of PDT in nasal decolonization of S. aureus in hemodialysis patients by measuring number of participants with successful decolonization of S. aureus

  30 patients will be recruited. Success of decolonization will be determined by serial culture of nare swabs for S. aureus.

  1 year

Study Arms (1)

single arm

EXPERIMENTAL

This is a single arm, open label study. Subjects who meet eligibility criteria will be treated with photodisinfection therapy (MRSAid™).

Device: photodynamic therapy (Ondine: MRSAid™)

Interventions

photodynamic therapy (Ondine: MRSAid™) DEVICE

Photodisinfection using MRSAid™ for the decolonization of S. aureus in hemodialysis patients

Also known as: MRSAid™

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: April 18, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share