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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
PAINTS Trial 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.Check my eligibility
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.See study design
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.
PAINTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (up to 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Staphylococcus aureus bloodstream infection
Secondary outcome measures
Incidence of Access related bloodstream infection by any pathogen
Incidence of Bloodstream infections by any pathogen
Incidence of Local access site infection
+3 morePAINTS 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.
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Who is running the clinical trial?
Agency for Healthcare Research and Quality (AHRQ)FED
401 Previous Clinical Trials
6,821,484 Total Patients Enrolled
Marin L. Schweizer, PhDLead Sponsor
Washington University School of MedicineOTHER
1,945 Previous Clinical Trials
2,303,523 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving peritoneal dialysis or hemodialysis at home.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Concurrent Control
- Group 2: Nasal Povidone-Iodine Decolonization Intervention
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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