Staphylococcus Aureus InfectionNCT02741869
Photodisinfection for the Decolonization of Staphylococcus Aureus in Hemodialysis Patients
A study testing photodynamic therapy (Ondine: MRSAid™) in people with Staphylococcus Aureus Infection and MSSA Colonization, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Infection, MSSA Colonization
- What is being tested?
- photodynamic therapy (Ondine: MRSAid™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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.
Read the detailed 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
- Conditions
- Staphylococcus Aureus Infection, MSSA Colonization
- Being tested
- photodynamic therapy (Ondine: MRSAid™)
- Keywords
- Staphylococcus aureus; nare carriage
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photodynamic therapy (Ondine: MRSAid™)Device
Also called MRSAid™
Photodisinfection using MRSAid™ for the decolonization of S. aureus in hemodialysis patients
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | This is a single arm, open label study. Subjects who meet eligibility criteria will be treated with photodisinfection therapy (MRSAid™). Receives: Device: photodynamic therapy (Ondine: MRSAid™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMay 2016 (estimated)
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: Investigator moved locations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus InfectionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741869
- Sponsor's protocol ID
- HD.SA-1
- Status last verified
- Aug 2018
- First submitted
- 29 Feb 2016
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodisinfection for the Decolonization of Staphylococcus Aureus in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02741869
- Acronym / sponsor ID
- HD.SA-1
- Conditions
- Staphylococcus Aureus Infection, MSSA Colonization
- Keywords
- Staphylococcus aureus; nare carriage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator moved locations.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- May 2016 (estimated)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: photodynamic therapy (Ondine: MRSAid™)This is a single arm, open label study. Subjects who meet eligibility criteria will be treated with photodisinfection therapy (MRSAid™). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photodynamic therapy (Ondine: MRSAid™)Also: MRSAid™Photodisinfection using MRSAid™ for the decolonization of S. aureus in hemodialysis patients | Device | single arm |
Primary outcome
The efficacy of PDT in nasal decolonization of S. aureus in hemodialysis patients by measuring number of participants with successful decolonization of S. aureus
Time frame: 1 year
30 patients will be recruited. Success of decolonization will be determined by serial culture of nare swabs for S. aureus.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing photodynamic therapy (Ondine: MRSAid™) in people with Staphylococcus Aureus Infection and MSSA Colonization, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of PDT in nasal decolonization of S. aureus in hemodialysis patients by measuring number of participants with successful decolonization of S. aureus (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.