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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02547103 |
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Date of registration:
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07/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
COSMO-PD |
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Scientific 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 |
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Date of first enrolment:
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June 1, 2016 |
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Target sample size:
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354 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02547103 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Kajohnsak Noppakun, Nephrologist |
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Address:
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Telephone:
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+6653946452 |
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Email:
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knoppaku@med.cmu.ac.th |
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Affiliation:
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Name:
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Surapon Nochaiwong |
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Address:
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Telephone:
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+6653991507 |
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Email:
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surapon.nochaiwong@gmail.com |
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Affiliation:
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Name:
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Chidchanok Ruengorn |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Pharmacy CMU |
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Key inclusion & exclusion 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:
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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End Stage Renal Disease
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Peritoneal Dialysis
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Intervention(s)
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Other: Chlorhexidine gluconate-soaked cloths
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Other: Normal saline
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Other: mupirocin ointment
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Primary Outcome(s)
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Incidence of PD-related infections
[Time Frame: 24 months]
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Secondary Outcome(s)
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Changes in health-related quality of life
[Time Frame: 24 months]
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Incidence of infection-related catheter removal
[Time Frame: 24 months]
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Incidence of hospitalization due to PD-related infection
[Time Frame: 24 months]
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Total healthcare costs
[Time Frame: 24 months]
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Incidence of death due to PD-related infection
[Time Frame: 24 months]
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Incidence of PD technical failure (change of modal of dialysis)
[Time Frame: 24 months]
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Number of participants with depression
[Time Frame: 24 months]
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Incidence of skin reactions
[Time Frame: 24 months]
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Changes in medication adherence
[Time Frame: 24 months]
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Rate of Staphylococcus aureus colonization
[Time Frame: 24 months]
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Secondary ID(s)
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THOR-PD Group
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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