Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients

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.

Timeline

Start

2019-11-01

Primary completion

2021-01-15

Completion

2021-07-12

Publications

• Background 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.
• Results 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.
• Results 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.
• 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.

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Indications