Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients

Renal Insufficiency, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047914
• Other study ID #: NASAL DECOLONIZATION
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 12, 2021

Study information

• Verified date: January 2023
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Infections are the leading cause of morbidity and the second leading cause of mortality among patients with chronic kidney disease (CKD) on renal replacement therapy. Staphylococcus aureus (S. aureus) is a major agent and previous nasal colonization represents an independent risk factor for infection. Up to 50% of these patients can be known to be colonized. With the global increase in bacterial resistance by S.aureus strategies for infection prevention and transmission by this agent are needed. The strategy of decolonization and elimination of nasal carrier status by S.aureus in dialytic chronic renal patients reduces infection rates, especially bacteremia. The gold standard for nasal decolonization is topical mupirocin treatment, but there are reports of increasing resistance especially after prolonged use, which limits the establishment of clinical protocols for the prevention of infection in the dialysis population. Antimicrobial Photodynamic Therapy (aPDT) proves to be a promising approach for its potential bactericidal effect, including multidrug-resistant bacteria and its low tendency to induce drug resistance.

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). Two other trained researchers 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,immediately after treatments, with a 3-month follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 12, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Photochemotherapy
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Antimicrobial Photodynamic therapy
Application 0.01% methylene blue with sterile swabs in each nostril with a 10-minute pre-irradiation • Light-emitting diode (? = 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.

Locations

Country	Name	City	State
Brazil	University of Nove de Julho (UNINOVE)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Prevalence of S.aureus	To evaluate the prevalence of both sensitive and methicillin-resistant S.aureus patients by bacterial culture and antibiogram in patients with renal chronic disease on dialysis treatment at the Hemodialysis Service of the University of São Paulo Medical School of Sao Paulo.	initial screening time to assess nasal staphylococcus aureus carrier before treatments
Secondary	Prevalence of recolonization	To evaluate the prevalence of recolonization by Staphylococcus aureus in the anterior nostril in through qualitative microbiological culture (presence or absence). The microbiological analysis was done by MALDI-TOF (Biomérieux) - Matrix Associated Laser Desorption-Ionization - Time of Flight.	01 and 03 months after treatments
Secondary	Anamnesis and risk factor collection	Guiding questions were applied to all patients. In addition to questions related to the patient's general health, demographic data (age, gender, marital status, occupation, education, housing), medical history data (etiology of CKD ( renal chronic disease), comorbidities, time of dialysis treatment until protocol initiation, presence smoking rate, type of venous access and time of use, kidney transplantation, systemic antibiotic therapy in the last 12 months, hospitalization or infection (including skin) in the last 12 months).	immediately after recruiting and accepting patients who met the inclusion/exclusion criteria
Secondary	Ontervention safety: photodynamic therapy	The analysis of adverse effects through a directed and open questionnaire, especially for this study	immediately after treatments, with a 3-month follow-up