Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection

Study Overview
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Brief Summary
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This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed up 24 months or completion of PD. The primary outcome is PD-related infection (PD-related peritonitis of exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. Costs include providers and patients expenses. The utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipated nephrologists and health care professional involving to PD in decision-making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.

Detailed Description
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Peritoneal dialysis (PD) is one of renal replacement therapy used for end-stage renal disease. Since 2011, there has been increasing numbers of patients under PD First policy of the Thai government. The most common PD related complication is PD-related infection categorized PD-related peritonitis, and exit site and tunnel infection. Although possible to treat PD-related infection, the incidence of technical failure and death due to peritonitis are still high in Thailand. PD-related infections mainly caused by Staphylococcus aureus. To prevent PD-related infection, cleaning with aseptic solvents using aseptic technique and prevent infection by prescribing prophylactic antibiotics are recommended. The International Society for Peritoneal Dialysis (ISPD) has recommended position statement of the regular use of mupirocin ointment around the catheter exits point and apply in nasal cavity. However, there is rising concern of long term use of mupirocin for mupirocin resistance of S. aureus. CHG is antiseptic use in clinical practice. It can coat at least 12 hours on skin and has anti-bacterial covered in both grams negative and positive. Several meta-analysis studies showed effectiveness of CHG in the prevention of hospitals infection i.e. reduces catheter-related sepsis, postoperative infection, and microbial resistance. According to PD-related infection, CHG has very little evidence of its effectiveness. This pilot study aims to evaluate effectiveness, safety, and cost-utility of CHG-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline and povidone-iodine) with aseptic technique in prevention of PD-related infections. It is a multicenter, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths. They will be followed up 24 months or completetion of PD. The primary outcome is PD-related infection (PD-related peritonitis or exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related quality of life, mental health, medication adherence, safety, adverse events related to treatments such as skin irritation, rash, etc. For cost-utility analysis, costs include providers and patients expenses. The Utility is assessed using EQ-5D-5L.

Official Title
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Efficacy and Safety of Local Application of Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection: A Double-Blind, Stratified Randomized Controlled Trial

Conditions
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End Stage Renal Disease, Peritoneal Dialysis

Intervention / Treatment
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* Other: Chlorhexidine gluconate-soaked cloths
* Other: Normal saline
* Other: mupirocin ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients with end-stage renal disease who were undergoing peritoneal dialysis; either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) Exclusion Criteria: History of psychological illness or condition that interferes with the ability to understand or comply with the requirements of the study Recent (within 1 month) exit-site or tunnel infection, or peritonitis Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin Current or recent (within 1 month) treatment with antibiotics administered by any route Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant S. aureus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine gluconate<br>Chlorhexidine gluconate-soaked cloths, clean topical area around catheter exit site with CHG 2% soaked cloths | Other: Chlorhexidine gluconate-soaked cloths<br> <br> |
| Active Comparator: Normal saline (usual care)<br>Normal saline, clean topical area around catheter exit site | Other: Normal saline<br> <br> |
| Active Comparator: Mupirocin ointment<br>Mupirocin ointment 2%, clean topical area around catheter exit site with Mupirocin ointment | Other: mupirocin ointment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PD-related infections | Peritonitis or exit-site and tunnel infection | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infection-related catheter removal | Peritonitis or exit-site and tunnel infection-related catheter removal | 24 months | 
| Incidence of hospitalization due to PD-related infection |  | 24 months | 
| Incidence of PD technical failure (change of modal of dialysis) | change of modal of dialysis | 24 months | 
| Incidence of death due to PD-related infection | Death due to peritonitis or exit-site and tunnel infection | 24 months | 
| Rate of Staphylococcus aureus colonization | Incidence of nasal or exit-site S. aureus colonization | 24 months | 
| Changes in health-related quality of life | Using the Kidney Disease Quality of Life-36 (KDQOL-36), EuroQoL-5 dimension-5 level (EQ-5D-5L) | 24 months | 
| Number of participants with depression | Using the Beck Depression Inventory II (BDI-II) | 24 months | 
| Changes in medication adherence | Using (i) directly observed to record the use of investigational medicinal products via return plastic sachets and ointment tubes; (ii) global rating on medication adherence by visual analog scale; and (iii) Medication-taking behavior measure for Thai patients (MTB-Thai questionnaire | 24 months | 
| Total healthcare costs | Direct medical costs, direct non-medical costs, and indirect costs | 24 months | 
| Incidence of skin reactions |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine gluconate, Mupirocin ointment, Normal saline, Peritonitis, Peritoneal dialysis