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

End Stage Renal Disease Clinical Trial

— COSMO-PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02547103
• Other study ID #: THOR-PD Group
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2016
• Est. completion date: August 2021

Study information

• Verified date: July 2019
• Source: Chiang Mai University
• Contact: Surapon Nochaiwong
• Phone: +6653991507
• Email: surapon.nochaiwong[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: August 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. History of psychological illness or condition that interferes with the ability to understand or comply with the requirements of the study

2. Recent (within 1 month) exit-site or tunnel infection, or peritonitis

3. Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin

4. Current or recent (within 1 month) treatment with antibiotics administered by any route

5. Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant S. aureus

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Peritoneal Dialysis

Intervention

Other:
• Chlorhexidine gluconate-soaked cloths

• Normal saline

• mupirocin ointment

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai

Sponsors (2)

Lead Sponsor	Collaborator
Chiang Mai University	Health Systems Research Institute, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety profiles	Safety of investigational medicinal products related to potential harm (e.g. participant survival, hospitalization, and emergency visit)	24 months
Primary	Incidence of PD-related infections	Peritonitis or exit-site and tunnel infection	24 months
Secondary	Incidence of infection-related catheter removal	Peritonitis or exit-site and tunnel infection-related catheter removal	24 months
Secondary	Incidence of hospitalization due to PD-related infection		24 months
Secondary	Incidence of PD technical failure (change of modal of dialysis)	change of modal of dialysis	24 months
Secondary	Incidence of death due to PD-related infection	Death due to peritonitis or exit-site and tunnel infection	24 months
Secondary	Rate of Staphylococcus aureus colonization	Incidence of nasal or exit-site S. aureus colonization	24 months
Secondary	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
Secondary	Number of participants with depression	Using the Beck Depression Inventory II (BDI-II)	24 months
Secondary	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
Secondary	Total healthcare costs	Direct medical costs, direct non-medical costs, and indirect costs	24 months
Secondary	Incidence of skin reactions		24 months

External Links

•   Faculty of Pharmacy, Chiang Mai University