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Nasal Povidone-Iodine for Staph Infection (PAINTS Trial)

Phase 4
Waitlist Available
Led By Marin L Schweizer, PhD
Research Sponsored by Marin L. Schweizer, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 3 years)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will test whether using nasal povidone-iodine at each hemodialysis session can prevent Staphylococcus aureus infections.

Who is the study for?
This trial is for adult patients who are undergoing outpatient chronic hemodialysis at one of the 16 study centers. It's not for those allergic to iodine, currently battling bacterial infections, under 18, on peritoneal or home hemodialysis, or pregnant women.
What is being tested?
The trial is testing if applying povidone-iodine ointment in the nose during each dialysis session can prevent Staphylococcus aureus infections. This stepped-wedge cluster randomized trial also assesses how feasible and acceptable this intervention is.
What are the potential side effects?
Potential side effects may include local skin reactions like redness or irritation where the povidone-iodine ointment is applied. Since it's a topical treatment, systemic side effects are less common but could include symptoms related to iodine sensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (up to 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Staphylococcus aureus bloodstream infection
Secondary study objectives
Incidence of Access related bloodstream infection by any pathogen
Incidence of Bloodstream infections by any pathogen
Incidence of Local access site infection
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nasal Povidone-Iodine Decolonization InterventionExperimental Treatment2 Interventions
Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.
Group II: Concurrent ControlActive Control1 Intervention
Standard of Care. This will be usual care at each hemodialysis center.

Find a Location

Who is running the clinical trial?

Agency for Healthcare Research and Quality (AHRQ)FED
406 Previous Clinical Trials
6,756,903 Total Patients Enrolled
Marin L. Schweizer, PhDLead Sponsor
Washington University School of MedicineOTHER
1,991 Previous Clinical Trials
2,295,582 Total Patients Enrolled

Media Library

Povidone-Iodine Topical Ointment Clinical Trial Eligibility Overview. Trial Name: NCT04210505 — Phase 4
Staph Infection Research Study Groups: Concurrent Control, Nasal Povidone-Iodine Decolonization Intervention
Staph Infection Clinical Trial 2023: Povidone-Iodine Topical Ointment Highlights & Side Effects. Trial Name: NCT04210505 — Phase 4
Povidone-Iodine Topical Ointment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04210505 — Phase 4
~59 spots leftby Nov 2025
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