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

NCT05251584 | Unknown

• 1 other identifier: PDRI-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis-related Infection

Keywords

Peritoneal dialysis-related infection; Infectious peritonitis; Exit-site infection; Infection rate; Drug susceptibility

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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 Outcomes (5)

• 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.

• 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.

• 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.

• Time to first peritoneal dialysis-related infection after gentamicin application

  Prospective period at least 1 year after entry to the study.

• 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.

Study Arms (1)

Mupirocin and Gentamicin

EXPERIMENTAL

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; Drug: Gentamicin

Interventions

Mupirocin DRUG

Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021

Also known as: BACIDAL

Mupirocin and Gentamicin

Gentamicin DRUG

Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022

Also known as: GENTREX

Mupirocin and Gentamicin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead
• Silpakorn University: collaborator

Study Sites (1)

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Interventions

Mupirocin; Gentamicins

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Ittaprach Yimsuk, PharmD

  College of Pharmacy, Rangsit university

  STUDY CHAIR

• Pamila Tasanavipas, MD

  Phramongkutklao hospital and College of Medicine

  STUDY DIRECTOR

• Daraporn Rungprai, BCP

  Faculty of Pharmacy, Silpakorn University

  STUDY DIRECTOR

• Wichai Santimaleeworagun, BCP

  Faculty of Pharmacy, Silpakorn University

  STUDY DIRECTOR

• Kulthida Chaijumroen, B.N.S.

  Phramongkutklao hospital and College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ittaprach Yimsuk, PharmD

CONTACT

097-237-4797; ittaprach.y@gmail.com

Pamila Tasanavipas, MD

CONTACT

081-344-2383; pa_tass@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group: topical mupirocin ointment retrospective period compare with gentamicin prospective period

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 22, 2022
• Study Start: December 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

TH (1)