Clinical trial NCT04047914: Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients
Official title: Antimicrobial Photodynamic Therapy in the Nasal Decolonization of Maintenance Hemodialysis Patients: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photochemotherapy
Renal Insufficiency, Chronic
Keywords: antimicrobial photodynamic therapy
Staphylococcus aureus
nasal decolonization
hemodialysis
chronic kidney disease
mupirocin
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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);

Primary outcomes:
measure: Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin
timeFrame: Before the intervention (T0)
measure: Qualitative culture (presence or absence bacterial colonies) after aPDT (antimicrobial photodynamic therapy) decolonization or mupirocin
timeFrame: Immediately after the completion of treatments (T1)
Secondary outcomes:
measure: Prevalence of S.aureus
timeFrame: initial screening time to assess nasal staphylococcus aureus carrier before treatments
measure: Prevalence of recolonization
timeFrame: 01 and 03 months after treatments
measure: Anamnesis and risk factor collection
timeFrame: immediately after recruiting and accepting patients who met the inclusion/exclusion criteria
measure: Ontervention safety: photodynamic therapy
timeFrame: immediately after treatments, with a 3-month follow-up
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Nove de Julho (UNINOVE)
Study officials:
affiliation: Nove de Julho University
name: Anna Carolina RT Horliana, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nove de Julho University
name: Daniella T Bezerra, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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 2003 Nov 20.