Staphylococcus Aureus Infection
Conditions
Keywords
Dialysis, povidone-iodine
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.
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.
Interventions
Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.
OTHERStandard Care
Control group will receive standard care as provided by the dialysis center
Sponsors
University of Pennsylvania
University of Illinois at Chicago
Washington University School of Medicine
Emory Healthcare
Agency for Healthcare Research and Quality (AHRQ)
3M
Marin L. Schweizer, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 |
Countries
United States
Outcome results
None listed