Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
COSMO-PD
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
1 other identifier
interventional
354
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJuly 29, 2019
July 1, 2019
5.1 years
September 7, 2015
July 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of PD-related infections
Peritonitis or exit-site and tunnel infection
24 months
Secondary Outcomes (10)
Incidence of 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)
24 months
Incidence of death due to PD-related infection
24 months
Rate of Staphylococcus aureus colonization
24 months
- +5 more secondary outcomes
Other Outcomes (1)
Safety profiles
24 months
Study Arms (3)
Chlorhexidine gluconate
EXPERIMENTALChlorhexidine gluconate-soaked cloths, clean topical area around catheter exit site with CHG 2% soaked cloths
Normal saline (usual care)
ACTIVE COMPARATORNormal saline, clean topical area around catheter exit site
Mupirocin ointment
ACTIVE COMPARATORMupirocin ointment 2%, clean topical area around catheter exit site with Mupirocin ointment
Interventions
Eligibility Criteria
You may qualify if:
- \. Patients with end-stage renal disease who were undergoing peritoneal dialysis; either continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiang Mai Universitylead
- Health Systems Research Institute,Thailandcollaborator
Study Sites (1)
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Related Publications (1)
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.
PMID: 31856900DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chidchanok Ruengorn
Faculty of Pharmacy CMU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty of Pharmacy
Study Record Dates
First Submitted
September 7, 2015
First Posted
September 11, 2015
Study Start
June 1, 2016
Primary Completion
June 30, 2021
Study Completion
August 1, 2021
Last Updated
July 29, 2019
Record last verified: 2019-07