Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 302
- 试验地点
- 5
- 主要终点
- Incidence of Staphylococcus aureus bloodstream infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Nasal Povidone-Iodine Decolonization Intervention
Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.
干预措施: Povidone-Iodine Topical Ointment (Drug)
Nasal Povidone-Iodine Decolonization Intervention
Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.
干预措施: Standard Care (Other)
结局指标
主要结局
Incidence of Staphylococcus aureus bloodstream infection
时间窗: 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
次要结局
- Incidence of Bloodstream infections by any pathogen(Through study completion (up to 3 years))
- Incidence of Staphylococcus aureus local access site infection(Through study completion (up to 3 years))
- Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)(Through study completion (up to 3 years))
- Incidence of Local access site infection(Through study completion (up to 3 years))
- Incidence of Access related bloodstream infection by any pathogen(Through study completion (up to 3 years))
- Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention(Through study completion (up to 3 years))
研究者
Marin L. Schweizer, PhD
Associate Professor
University of Iowa