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Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection (COSMO-PD)

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ClinicalTrials.gov Identifier: NCT02547103
Recruitment Status : Recruiting
First Posted : September 11, 2015
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Health Systems Research Institute, Thailand
Information provided by (Responsible Party):
Chidchanok Ruengorn, Chiang Mai University

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Peritoneal Dialysis Other: Chlorhexidine gluconate-soaked cloths Other: Normal saline Other: mupirocin ointment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 2021


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



Primary Outcome Measures :
  1. Incidence of PD-related infections [ Time Frame: 24 months ]
    Peritonitis or exit-site and tunnel infection


Secondary Outcome Measures :
  1. Incidence of infection-related catheter removal [ Time Frame: 24 months ]
    Peritonitis or exit-site and tunnel infection-related catheter removal

  2. Incidence of hospitalization due to PD-related infection [ Time Frame: 24 months ]
  3. Incidence of PD technical failure (change of modal of dialysis) [ Time Frame: 24 months ]
    change of modal of dialysis

  4. Incidence of death due to PD-related infection [ Time Frame: 24 months ]
    Death due to peritonitis or exit-site and tunnel infection

  5. Rate of Staphylococcus aureus colonization [ Time Frame: 24 months ]
    Incidence of nasal or exit-site S. aureus colonization

  6. Changes in health-related quality of life [ Time Frame: 24 months ]
    Using the Kidney Disease Quality of Life-36 (KDQOL-36), EuroQoL-5 dimension-5 level (EQ-5D-5L)

  7. Number of participants with depression [ Time Frame: 24 months ]
    Using the Beck Depression Inventory II (BDI-II)

  8. Changes in medication adherence [ Time Frame: 24 months ]
    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

  9. Total healthcare costs [ Time Frame: 24 months ]
    Direct medical costs, direct non-medical costs, and indirect costs

  10. Incidence of skin reactions [ Time Frame: 24 months ]

Other Outcome Measures:
  1. Safety profiles [ Time Frame: 24 months ]
    Safety of investigational medicinal products related to potential harm (e.g. participant survival, hospitalization, and emergency visit)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547103


Contacts
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Contact: Surapon Nochaiwong +6653991507 surapon.nochaiwong@gmail.com
Contact: Chidchanok Ruengorn +6653991507 mei.ruengorn@gmail.com

Locations
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Thailand
Maharaj Nakorn Chiang Mai Hospital Recruiting
Chiang Mai, Thailand, 50200
Contact: Kajohnsak Noppakun, Nephrologist    +6653946452    knoppaku@med.cmu.ac.th   
Contact: Chayutthaphong Chaisai, Pharmacist    +6653941507    c.chayutthaphong@gmail.com   
Sponsors and Collaborators
Chiang Mai University
Health Systems Research Institute, Thailand
Investigators
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Study Director: Chidchanok Ruengorn Faculty of Pharmacy CMU
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chidchanok Ruengorn, Faculty of Pharmacy, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02547103    
Other Study ID Numbers: THOR-PD Group
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chidchanok Ruengorn, Chiang Mai University:
Chlorhexidine gluconate
Mupirocin ointment
Normal saline
Peritonitis
Peritoneal dialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chlorhexidine
Chlorhexidine gluconate
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action