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

February 13, 2022 updated by: Phramongkutklao College of Medicine and Hospital

Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection Caused by Pseudomonas Aeruginosa

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Phramongkutklao Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ittaprach Yimsuk, PharmD
        • Principal Investigator:
          • Pamila Tasanavipas, MD
        • Principal Investigator:
          • Daraporn Rungprai, BCP
        • Sub-Investigator:
          • Wichai Santimaleeworagun, BCP
        • Sub-Investigator:
          • Kulthida Chaijumroen, B.N.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mupirocin and 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.
Drug: Mupirocin
Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021
Other Names:
  • BACIDAL
Drug: Gentamicin
Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022
Other Names:
  • GENTREX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Exit-site infection in mupirocin compared with gentamicin group
Time Frame: 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.
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.
Rate of Infectious peritonitis in mupirocin compared with gentamicin group
Time Frame: 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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
Time Frame: 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
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.
Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group
Time Frame: 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
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.
Percentage of catheter removal due to peritoneal dialysis-related infection
Time Frame: 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
Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
Time to first peritoneal dialysis-related infection after gentamicin application
Time Frame: 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
Prospective period at least 1 year after entry to the study.
Drug susceptibility of causative pathogens of peritoneal dialysis-related infection
Time Frame: 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
Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Collaborators

Silpakorn University

Investigators

  • Study Director: Daraporn Rungprai, BCP, Faculty of Pharmacy, Silpakorn University
  • Study Chair: Ittaprach Yimsuk, PharmD, College of Pharmacy, Rangsit university
  • Study Director: Pamila Tasanavipas, MD, Phramongkutklao hospital and College of Medicine
  • Study Director: Wichai Santimaleeworagun, BCP, Faculty of Pharmacy, Silpakorn University
  • Principal Investigator: Kulthida Chaijumroen, B.N.S., Phramongkutklao hospital and College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

February 13, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 13, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDRI-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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