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Nasal Decolonization of Dialysis Patients Noses

NCT04210505 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2023-06-28

No results posted yet for this study

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.

Conditions

  • Staphylococcus Aureus Infection

Interventions

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

Sponsors & Collaborators

  • University of Pennsylvania

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Emory Healthcare

    collaborator OTHER

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • 3M

    collaborator INDUSTRY

  • Marin L. Schweizer, PhD

    lead OTHER

Principal Investigators

  • Marin L Schweizer, PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210505 on ClinicalTrials.gov