Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients

NCT04047914 | Completed

• 1 other identifier: NASAL DECOLONIZATION
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study will be to evaluate the effect of Antimicrobial Photodynamic Therapy (aPDT) in the Nasal Decolonization of Dialytic Chronic Renal Patients, Staphylococcus Aureus (S.aureus) Carriers This is a 3-months follow-up, randomized, single-blind, prospective controlled trial, single-center and will happen in 02 phases: Phase 1 - Epidemiological Evaluation - A researcher will invite the research participants who are undergoing treatment at the Hemodialysis Service of Clinical Hospital and explain its contents. After reading and signing the informed consent, this same researcher (calibrated for the experiment) will perform nasal secretion microbiological collections to identify patients colonized by S.aureus in the anterior nostril (nasal carrier) - baseline T0 and the application of the questionnaire that identifies possible factors that may be considered as risk for colonization and possible development of diseases related to S. aureus. In the laboratory of Microbiology, the strains will be identified and the colonized patients will be invited to continue the study (Phase 2). Non-carrier patients will only be counseled with infection prevention care. Phase 2 - Parallel clinical trial with two intervention groups (aPDT or Mupirocin) - Patients with nasal aureus (thirty-four colonized patients aged over 18 years) will be treated with aPDT (experimental group) or mupirocin (control group). A trained researcher will collect new aliquots of nasal discharge after completion of nostril treatment (T1) to check for decolonization by culture. A new collection will be performed at 1 (T2) and 3 (T3) months after treatment to assess recolonization. It was evaluated intervention safety (photodynamic therapy) through a directed and open questionnaire about adverse effects.

Conditions

Photochemotherapy; Renal Insufficiency, Chronic

Keywords

antimicrobial photodynamic therapy; Staphylococcus aureus; nasal decolonization; hemodialysis; chronic kidney disease; mupirocin

Outcome Measures

Primary Outcomes (2)

• Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin

  The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Fligh

  Before the intervention (T0)

• Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin

  The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Fligh

  Immediately after the completion of treatments (T1)

Secondary Outcomes (4)

• Prevalence of S.aureus

  initial screening time to assess nasal staphylococcus aureus carrier before treatments

• Prevalence of recolonization

  01 and 03 months after treatments

• Anamnesis and risk factor collection

  immediately after recruiting and accepting patients who met the inclusion/exclusion criteria

• Ontervention safety: photodynamic therapy

  immediately after treatments, with a 3-month follow-up

Study Arms (2)

experimental aPDT group

EXPERIMENTAL

Application of 0.01% methylene blue with enough sterile swab to cover the inner nostril extension with a 10 minute pre-irradiation time. The irradiations were carried out with a red light-emitting diode (LED) (λ = 660 nm), for 300 seconds, irradiance of 400 mW / cm2, radiant exposure 124 J / cm2, with uniform application in each anterior nostril.

Device: Antimicrobial Photodynamic therapy

control mupirocin group

ACTIVE COMPARATOR

A standard treatment will be performed conventionally with topical mupirocin. Will be performed with 2% Mupirocin Ointment, to be applied to the anterior nostrils twice a day for 5 days.

Drug: Mupirocin ointment

Interventions

Antimicrobial Photodynamic therapy DEVICE

Application 0.01% methylene blue with sterile swabs in each nostril with a 10-minute pre-irradiation • Light-emitting diode (λ = 660 nm), for 300 seconds, with an irradiance of 400 mW / cm2

Also known as: Photochemotherapy

experimental aPDT group

Mupirocin ointment DRUG

Performed with 2% Mupirocin Ointment, to be applied to the anterior nostrils twice a day for 5 days.

Also known as: Mupirocin Nasal Product

control mupirocin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nasal carriers of S.aureus
• chronic kidney patient undergoing hemodialysis treatment;
• aged over 18 years;
• both genders;

You may not qualify if:

• pregnancy or breastfeeding;
• presence of nasal foreign body;
• history of nasal surgery in the last 3 months;
• active infection by S. aureus;
• use of topical nasal or systemic antibiotic in the last three months;
• history of severe allergy to mupirocin or methylene blue (MB);

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

Location

Related Publications (4)

• Fu XJ, Fang Y, Yao M. Antimicrobial photodynamic therapy for methicillin-resistant Staphylococcus aureus infection. Biomed Res Int. 2013;2013:159157. doi: 10.1155/2013/159157. Epub 2013 Feb 28.

  PMID: 23555074 BACKGROUND

• Wertheim HF, Melles DC, Vos MC, van Leeuwen W, van Belkum A, Verbrugh HA, Nouwen JL. The role of nasal carriage in Staphylococcus aureus infections. Lancet Infect Dis. 2005 Dec;5(12):751-62. doi: 10.1016/S1473-3099(05)70295-4.

  PMID: 16310147 RESULT

• Tacconelli E, Carmeli Y, Aizer A, Ferreira G, Foreman MG, D'Agata EM. Mupirocin prophylaxis to prevent Staphylococcus aureus infection in patients undergoing dialysis: a meta-analysis. Clin Infect Dis. 2003 Dec 15;37(12):1629-38. doi: 10.1086/379715. Epub 2003 Nov 20.

  PMID: 14689344 RESULT

• Bezerra DT, La Selva A, Cecatto RB, Deana AM, Prates RA, Bussadori SK, Mesquita-Ferrari RA, Motta LJ, Fernandes KPS, Martimbianco ALC, Frochot C, Pereira BJ, Rossi F, Mimica MJ, Horliana ACRT. Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial. Am J Kidney Dis. 2023 May;81(5):528-536.e1. doi: 10.1053/j.ajkd.2022.09.013. Epub 2022 Nov 14.

  PMID: 36396084 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Staphylococcal Infections

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Anna Carolina RT Horliana, phD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

• Daniella T Bezerra, phD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for performing the treatments (which will open the randomization envelopes) will know which treatment is assigned to each patient. The researcher responsible for collecting the microbiological samples (nasal discharge) and the microbiologist will be blind to the treatments assigned to the groups (they do not know the nature of treatments). The patient will not be blinded in view of the difference between the nature of the treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd, clinical professor

Model Details: 34 individuals will be randomly divided into 2 groups: G1 - Experimental Group (n = 17) - Treatment will be performed with methylene blue and red light-emitting diode (LED) in the nostrils. G2 - Control group (n = 17) - Standard treatment will be performed conventionally with topical mupirocin.

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 7, 2019
• Study Start: November 1, 2019
• Primary Completion: January 15, 2021
• Study Completion: July 12, 2021
• Last Updated: July 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)