Clinical trial NCT04210505: Nasal Decolonization of Dialysis Patients Noses
Official title: Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Staphylococcus Aureus Infection
Keywords: Dialysis
povidone-iodine
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Illinois at Chicago
name: Washington University School of Medicine
name: Emory Healthcare
name: Agency for Healthcare Research and Quality (AHRQ)
name: 3M
First posted: 2019-12-24
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hemodialysis patients are at high-risk for infections, specifically Staphylococcus aureus infections. The investigators propose to 1) implement a novel intervention (nasal povidone-iodine at each hemodialysis session) to prevent S. aureus infections using a stepped-wedge cluster randomized trial, and 2) evaluate the feasibility and acceptability of this intervention. If successful, this intervention can be used among hemodialysis patients, and evaluated in other high-risk patient populations to prevent S. aureus infections.

Detailed description: The PAINTS study is a stepped-wedge cluster randomized trial that will compare standard care to an intervention that includes nasal povidone-iodine at each hemodialysis session to determine whether nasal povidone-iodine prevents infections. The nasal povidone-iodine will be donated by 3M. This formulation of nasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product.

Eligibility criteria: Inclusion Criteria:

* Adult patients receiving outpatient chronic hemodialysis at one of the 16 study dialysis centers.

Note: the unit of randomization is the dialysis center, not the individual patient

Exclusion Criteria:

Patients receiving peritoneal dialysis or home hemodialysis Pregnant women Patients with known sensitivity or allergy to iodine (documented or verbalized) Patients with active bacterial infections Children \< 18 years of age. Patients with infections at the beginning of the study will enter the study after antibiotic treatment is complete.

Primary outcomes:
measure: Incidence of Staphylococcus aureus bloodstream infection
timeFrame: Through study completion (up to 3 years)
Secondary outcomes:
measure: Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)
timeFrame: Through study completion (up to 3 years)
measure: Incidence of Staphylococcus aureus local access site infection
timeFrame: Through study completion (up to 3 years)
measure: Incidence of Bloodstream infections by any pathogen
timeFrame: Through study completion (up to 3 years)
measure: Incidence of Access related bloodstream infection by any pathogen
timeFrame: Through study completion (up to 3 years)
measure: Incidence of Local access site infection
timeFrame: Through study completion (up to 3 years)
measure: Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention
timeFrame: Through study completion (up to 3 years)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Wisconsin, Madison
name: Marin L Schweizer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Racila AM, O'Shea AMJ, Nair R, Dukes K, Herwaldt LA, Boyken L, Diekema D, Ward MA, Cobb J, Jacob J, Pegues D, Bleasdale S, Vijayan A, Mutneja A, Fraer M, O'Connell-Moore D, Tolomeo P, Mendez M, Jaworski E, Schweizer ML. Using nasal povidone-iodine to prevent bloodstream infections and transmission of Staphylococcus aureus among haemodialysis patients: a stepped-wedge cluster randomised control trial protocol. BMJ Open. 2021 Dec 3;11(12):e048830. doi: 10.1136/bmjopen-2021-048830.