Nasal Decolonization of Dialysis Patients Noses

Staphylococcus Aureus Infection Clinical Trial

— PAINTS  

Official title:

Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04210505
• Other study ID #: Pending
• Secondary ID: 1R01HS026724
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 29, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 302
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Staphylococcal Infections
• Staphylococcus Aureus Infection

Intervention

Drug:
• Povidone-Iodine Topical Ointment
Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.

Other:
• Standard Care
Control group will receive standard care as provided by the dialysis center

Locations

Country	Name	City	State
United States	Emory Healthcare	Atlanta	Georgia
United States	University of Illinois Chicago	Chicago	Illinois
United States	University of Iowa	Iowa City	Iowa
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri

Sponsors (7)

Lead Sponsor	Collaborator
Marin L. Schweizer, PhD	3M, Agency for Healthcare Research and Quality (AHRQ), Emory Healthcare, University of Illinois at Chicago, University of Pennsylvania, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Staphylococcus aureus bloodstream infection	Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: a Staphylococcus aureus positive blood specimen collected in the outpatient setting or within 1 calendar day after a hospital admission	Through study completion (up to 3 years)
Secondary	Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)	Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: a Staphylococcus aureus bloodstream infection with the suspected source reported as the vascular access or uncertain	Through study completion (up to 3 years)
Secondary	Incidence of Staphylococcus aureus local access site infection	Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: pus, redness or increased swelling at the vascular access site when an ARBSI is not present but with positive culture for Staphylococcus aureus	Through study completion (up to 3 years)
Secondary	Incidence of Bloodstream infections by any pathogen	Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network definition: a positive blood specimen collected in the outpatient setting or within 1 calendar day after a hospital admission	Through study completion (up to 3 years)
Secondary	Incidence of Access related bloodstream infection by any pathogen	Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network definition: a bloodstream infection with the suspected source reported as the vascular access or uncertain	Through study completion (up to 3 years)
Secondary	Incidence of Local access site infection	Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: pus, redness or increased swelling at the vascular access site when an ARBSI is not present	Through study completion (up to 3 years)
Secondary	Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention	Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network	Through study completion (up to 3 years)