Nasal Decolonization of Dialysis Patients Noses (PAINTS)

Marin L. Schweizer, PhD

Status and phase: Active, not recruiting; Phase 4

Conditions: Staphylococcus Aureus Infection

Treatments: Drug: Povidone-Iodine Topical Ointment; Other: Standard Care

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT04210505

Pending

1R01HS026724 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Nasal Povidone-Iodine Decolonization Intervention

Experimental group

Description:

Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.

Treatment:

Drug: Povidone-Iodine Topical Ointment

Other: Standard Care

Concurrent Control

No Intervention group

Description:

Standard of Care. This will be usual care at each hemodialysis center.