Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection

Not Applicable

• Conditions: Peritoneal Dialysis-related Infection
• Interventions: Drug: Mupirocin; Drug: Gentamicin

• Registration Number: NCT05251584
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period. Rate of catheter removal, time to first peritoneal dialysis-related infection after apply gentamicin cream.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-01-04
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-13
• Last Update Submitted: 2022-02-13
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22
• Primary Completion: 2023-03-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age greater than or equal to 20 years
• End stage renal disease patients on peritoneal dialysis follow up at Phramongkutklao hospital's peritoneal dialysis clinic between January 1, 2021 to March 31, 2023
• Start peritoneal dialysis or follow up at Phramongkutklao hospital's peritoneal dialysis clinic at least 90 days before recruited
• Use topical mupirocin ointment for prevention of peritoneal dialysis-related infection between January 1, 2021 to December 31, 2021
• Can be used LINE application throughout the study

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Exclusion Criteria

• Allergy to gentamicin or components
• Previous systemic antibiotics use within 90 days before recruited
• Previous peritoneal dialysis-related infection within 28 days before recruited
• Immunosuppressants used
• Prospective follow up less than 2 months
• Don't sign informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mupirocin and Gentamicin	Mupirocin	2% mupirocin ointments apply at exit-site once daily after wound cleaning before recruit in the study then use 0.1% gentamicin cream apply at exit-site once daily after wound cleaning after entry to the study.
Mupirocin and Gentamicin	Gentamicin	2% mupirocin ointments apply at exit-site once daily after wound cleaning before recruit in the study then use 0.1% gentamicin cream apply at exit-site once daily after wound cleaning after entry to the study.

Primary Outcome Measures

Name	Time	Method
Rate of Exit-site infection in mupirocin compared with gentamicin group	All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.	Exit-site infection diagnosis by physician. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group.
Rate of Infectious peritonitis in mupirocin compared with gentamicin group	All infectious peritonitis episodes occurred last year in mupirocin group and all infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.	Infectious peritonitis diagnosis by physicians. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group

Secondary Outcome Measures

Name	Time	Method
Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group	All pathogenic organisms of infectious peritonitis episodes occurred last year in mupirocin group and all pathogenic organisms of infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year.	Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Percentage of catheter removal due to peritoneal dialysis-related infection	Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.	Prospective data collection from patient's medical records in gentamicin group
Time to first peritoneal dialysis-related infection after gentamicin application	Prospective period at least 1 year after entry to the study.	Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group. Peritoneal-related infection diagnosis by physicians. Prospective data collection from patient's medical records in gentamicin group
Drug susceptibility of causative pathogens of peritoneal dialysis-related infection	Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.	Drug susceptibility test by broth micro-dilution and E-test. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group	All pathogenic organisms of exit-site infection episodes occurred last year in mupirocin group and all pathogenic organisms of exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year.	Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group

Trial Locations

Locations (1)

Phramongkutklao Hospital; 🇹🇭 Ratchathewi, Bangkok, Thailand