PAINTS: Nasal Decolonization of Dialysis Patients Noses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nasal Povidone-Iodine Decolonization Intervention Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session. |
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
|
| No Intervention: Concurrent Control Standard of Care. This will be usual care at each hemodialysis center. |
Outcome Measures
Primary Outcome Measures
- Incidence of Staphylococcus aureus bloodstream infection [Through study completion (up to 3 years)]
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
Secondary Outcome Measures
- Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI) [Through study completion (up to 3 years)]
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
- Incidence of Staphylococcus aureus local access site infection [Through study completion (up to 3 years)]
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
- Incidence of Bloodstream infections by any pathogen [Through study completion (up to 3 years)]
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
- Incidence of Access related bloodstream infection by any pathogen [Through study completion (up to 3 years)]
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
- Incidence of Local access site infection [Through study completion (up to 3 years)]
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
- Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention [Through study completion (up to 3 years)]
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory Healthcare | Atlanta | Georgia | United States | 30322 |
| 2 | University of Illinois Chicago | Chicago | Illinois | United States | 60612 |
| 3 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 4 | Washington University | Saint Louis | Missouri | United States | 63110 |
| 5 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Marin L. Schweizer, PhD
- University of Pennsylvania
- University of Illinois at Chicago
- Washington University School of Medicine
- Emory Healthcare
- Agency for Healthcare Research and Quality (AHRQ)
- 3M
Investigators
- Principal Investigator: Marin L Schweizer, PhD, University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pending
- 1R01HS026724