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

Primary Purpose

Peritoneal Dialysis-related Infection

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Mupirocin
Gentamicin
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peritoneal Dialysis-related Infection focused on measuring Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Infection rate, Drug susceptibility

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phramongkutklao HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mupirocin and Gentamicin

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of Exit-site infection in mupirocin compared with gentamicin group
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
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

Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
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 Infectious peritonitis in mupirocin compared with gentamicin group
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
Prospective data collection from patient's medical records in gentamicin group
Time to first peritoneal dialysis-related infection after gentamicin application
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
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

Full Information

First Posted
January 4, 2022
Last Updated
February 13, 2022
Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Silpakorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05251584
Brief Title
Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection
Official Title
Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection Caused by Pseudomonas Aeruginosa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Silpakorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis-related Infection
Keywords
Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Infection rate, Drug susceptibility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group: topical mupirocin ointment retrospective period compare with gentamicin prospective period
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mupirocin and Gentamicin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mupirocin
Other Intervention Name(s)
BACIDAL
Intervention Description
Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021
Intervention Type
Drug
Intervention Name(s)
Gentamicin
Other Intervention Name(s)
GENTREX
Intervention Description
Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022
Primary Outcome Measure Information:
Title
Rate of Exit-site infection in mupirocin compared with gentamicin group
Description
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.
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.
Title
Rate of Infectious peritonitis in mupirocin compared with gentamicin group
Description
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
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.
Secondary Outcome Measure Information:
Title
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
Description
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in 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.
Title
Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group
Description
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in 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.
Title
Percentage of catheter removal due to peritoneal dialysis-related infection
Description
Prospective data collection from patient's medical records in gentamicin group
Time Frame
Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
Title
Time to first peritoneal dialysis-related infection after gentamicin application
Description
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
Time Frame
Prospective period at least 1 year after entry to the study.
Title
Drug susceptibility of causative pathogens of peritoneal dialysis-related infection
Description
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
Time Frame
Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ittaprach Yimsuk, PharmD
Phone
097-237-4797
Email
ittaprach.y@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pamila Tasanavipas, MD
Phone
081-344-2383
Email
pa_tass@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ittaprach Yimsuk, PharmD
Organizational Affiliation
College of Pharmacy, Rangsit university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pamila Tasanavipas, MD
Organizational Affiliation
Phramongkutklao hospital and College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daraporn Rungprai, BCP
Organizational Affiliation
Faculty of Pharmacy, Silpakorn University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wichai Santimaleeworagun, BCP
Organizational Affiliation
Faculty of Pharmacy, Silpakorn University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kulthida Chaijumroen, B.N.S.
Organizational Affiliation
Phramongkutklao hospital and College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phramongkutklao Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ittaprach Yimsuk, PharmD
Phone
097-237-4797
Email
ittaprach.y@gmail.com
First Name & Middle Initial & Last Name & Degree
Pamila Tasanavipas, MD
Phone
081-344-2383
Email
pa_tass@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ittaprach Yimsuk, PharmD
First Name & Middle Initial & Last Name & Degree
Pamila Tasanavipas, MD
First Name & Middle Initial & Last Name & Degree
Daraporn Rungprai, BCP
First Name & Middle Initial & Last Name & Degree
Wichai Santimaleeworagun, BCP
First Name & Middle Initial & Last Name & Degree
Kulthida Chaijumroen, B.N.S.

12. IPD Sharing Statement

Learn more about this trial

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

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