Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial

NASAL DECOLONIZATION

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.

2019-11-01

2021-01-15

2021-07-12

Completed

34

Inclusion Criteria: * nasal carriers of S.aureus * chronic kidney patient undergoing hemodialysis treatment; * aged over 18 years; * both genders; Exclusion Criteria: * 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);

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': '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.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

2023-07-03