NCT04210505

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
302

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2020

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

3.3 years

First QC Date

December 18, 2019

Last Update Submit

June 26, 2023

Conditions

Staphylococcus Aureus Infection

Keywords

Dialysispovidone-iodine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)

    Through study completion (up to 3 years)

  • Incidence of Staphylococcus aureus local access site infection

    Through study completion (up to 3 years)

  • Incidence of Bloodstream infections by any pathogen

    Through study completion (up to 3 years)

  • Incidence of Access related bloodstream infection by any pathogen

    Through study completion (up to 3 years)

  • Incidence of Local access site infection

    Through study completion (up to 3 years)

  • +1 more secondary outcomes

Study Arms (2)

Nasal Povidone-Iodine Decolonization Intervention

EXPERIMENTAL

Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.

Drug: Povidone-Iodine Topical OintmentOther: Standard Care

Concurrent Control

NO INTERVENTION

Standard of Care. This will be usual care at each hemodialysis center.

Interventions

Povidone-Iodine Topical OintmentDRUG

Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.

Nasal Povidone-Iodine Decolonization Intervention
Standard CareOTHER

Control group will receive standard care as provided by the dialysis center

Nasal Povidone-Iodine Decolonization Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Emory Healthcare

Atlanta, Georgia, 30322, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Armstrong-Pavlik F, Racila AM, Ward M, Nair R, Tolomeo P, Kellogg J, Lindsey B, Herwaldt LA, Jacob JT, Vijayan A, Pegues D, Cobb J, Fraer M, Casey SB, Dukes KC, Hockett Sherlock S, Hopps M, Schweizer ML. Survey of hemodialysis patients' knowledge of their infection risk and acceptability of an intranasal decolonization intervention. Infect Control Hosp Epidemiol. 2026 Feb 4:1-5. doi: 10.1017/ice.2025.10386. Online ahead of print.

    PMID: 41635193DERIVED

  • 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.

    PMID: 34862278DERIVED

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Marin L Schweizer, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 24, 2019

Study Start

September 29, 2020

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

The investigators will submit an electronic version of each peer-reviewed accepted manuscript to PubMed Central to be made publicly available within 12 months of publication. The investigators will respond to requests for restricted public health data sets and ensure responses follow appropriate processes, documentation, and approval.

Shared Documents
STUDY PROTOCOL
Time Frame
Until year 2025
Access Criteria
Upon request

Locations

US(5)