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Staphylococcus Aureus InfectionPhase 4PAINTSNCT04210505

Nasal Decolonization of Dialysis Patients Noses

A Phase 4 study testing Povidone-Iodine Topical Ointment in people with Staphylococcus Aureus Infection, run by Marin L. Schweizer, PhD at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Staphylococcus Aureus Infection
What is being tested?
Povidone-Iodine Topical Ointment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
5 sitesUnited States
Study dates
29 Sep 2020to 31 Jan 2024
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory Healthcare

    Atlanta, Georgia, 30322

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)

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.

Read the 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.

Being tested
Povidone-Iodine Topical Ointment, Standard Care
Keywords
Dialysis, povidone-iodine
Medical subject headings
Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Povidone-Iodine Topical OintmentDrug

    Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.

  • Standard CareOther

    Control group will receive standard care as provided by the dialysis center

Study groups in NCT04210505
Study groupRoleWhat they receive
Nasal Povidone-Iodine Decolonization InterventionExperimentalIntranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.
Receives: Drug: Povidone-Iodine Topical Ointment; Other: Standard Care
Concurrent ControlNo interventionStandard of Care. This will be usual care at each hemodialysis center.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Staphylococcus aureus bloodstream infection

    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

    Measured: Through study completion (up to 3 years)

Secondary outcomes (6)

  1. Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)

    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

    Measured: Through study completion (up to 3 years)

  2. Incidence of Staphylococcus aureus local access site infection

    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

    Measured: Through study completion (up to 3 years)

  3. Incidence of Bloodstream infections by any pathogen

    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

    Measured: Through study completion (up to 3 years)

  4. Incidence of Access related bloodstream infection by any pathogen

    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

    Measured: Through study completion (up to 3 years)

  5. Incidence of Local access site infection

    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

    Measured: Through study completion (up to 3 years)

  6. Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention

    Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network

    Measured: Through study completion (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2019
  2. Study start29 Sep 2020
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210505
Sponsor's protocol ID
Pending
Other IDs
1R01HS026724
Acronym
PAINTS
Status last verified
Jun 2023
First submitted
18 Dec 2019
Last updated
28 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The investigators will submit an electronic version of each peer-reviewed accepted manuscript to PubMed Central to be made publicly available within 12 months of publication. The investigators will respond to requests for restricted public health data sets and ensure responses follow appropriate processes, documentation, and approval.

Publications

  • Armstrong-Pavlik F, Racila AM, Ward M, Nair R, Tolomeo P, Kellogg J, Lindsey B, Herwaldt LA, Jacob JT, Vijayan A, Pegues D, Cobb J, Fraer M, Casey SB, Dukes KC, Hockett Sherlock S, Hopps M, Schweizer ML. Survey of hemodialysis patients' knowledge of their infection risk and acceptability of an intranasal decolonization intervention. Infect Control Hosp Epidemiol. 2026 Mar;47(3):252-256. doi: 10.1017/ice.2025.10386. Epub 2026 Feb 4.

    PubMed 41635193

  • Racila AM, O'Shea AMJ, Nair R, Dukes K, Herwaldt LA, Boyken L, Diekema D, Ward MA, Cobb J, Jacob J, Pegues D, Bleasdale S, Vijayan A, Mutneja A, Fraer M, O'Connell-Moore D, Tolomeo P, Mendez M, Jaworski E, Schweizer ML. Using nasal povidone-iodine to prevent bloodstream infections and transmission of Staphylococcus aureus among haemodialysis patients: a stepped-wedge cluster randomised control trial protocol. BMJ Open. 2021 Dec 3;11(12):e048830. doi: 10.1136/bmjopen-2021-048830.

    PubMed 34862278

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Povidone-Iodine Topical Ointment in people with Staphylococcus Aureus Infection, run by Marin L. Schweizer, PhD at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Staphylococcus aureus bloodstream infection (time frame: Through study completion (up to 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04210505, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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