Clinical trial NCT02547103: Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: End Stage Renal Disease
Peritoneal Dialysis
Keywords: Chlorhexidine gluconate
Mupirocin ointment
Normal saline
Peritonitis
Peritoneal dialysis
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
Collaborators: name: Health Systems Research Institute,Thailand
First posted: 2015-09-11
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of PD-related infections
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of infection-related catheter removal
timeFrame: 24 months
measure: Incidence of hospitalization due to PD-related infection
timeFrame: 24 months
measure: Incidence of PD technical failure (change of modal of dialysis)
timeFrame: 24 months
measure: Incidence of death due to PD-related infection
timeFrame: 24 months
measure: Rate of Staphylococcus aureus colonization
timeFrame: 24 months
measure: Changes in health-related quality of life
timeFrame: 24 months
measure: Number of participants with depression
timeFrame: 24 months
measure: Changes in medication adherence
timeFrame: 24 months
measure: Total healthcare costs
timeFrame: 24 months
measure: Incidence of skin reactions
timeFrame: 24 months
Other outcomes:
measure: Safety profiles
timeFrame: 24 months
Locations:
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
Study officials:
affiliation: Faculty of Pharmacy CMU
name: Chidchanok Ruengorn
role: STUDY_DIRECTOR
References:
citation: Nochaiwong S, Ruengorn C, Noppakun K, Panyathong S, Dandecha P, Sood MM, Saenjum C, Awiphan R, Sirilun S, Mongkhon P, Chongruksut W, Thavorn K; Thai Renal Outcomes Research (THOR) Investigators. Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol. Trials. 2019 Dec 19;20(1):754. doi: 10.1186/s13063-019-3953-8.