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Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients

NCT04047914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-07-03

No results posted yet for this study

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

Interventions

DEVICE

Antimicrobial Photodynamic therapy

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

DRUG

Mupirocin ointment

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

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Principal Investigators

  • Anna Carolina RT Horliana, phD · Nove de Julho University

  • Daniella T Bezerra, phD · Nove de Julho University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-01-15
Completion
2021-07-12

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04047914 on ClinicalTrials.gov