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

NCT ID: NCT05251584

Last Updated: 2022-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-05-31

Brief Summary

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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

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Conditions

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Peritoneal Dialysis-related Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group: topical mupirocin ointment retrospective period compare with gentamicin prospective period
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mupirocin

Intervention Type DRUG

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

Gentamicin

Intervention Type DRUG

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

Interventions

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Mupirocin

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

Intervention Type DRUG

Gentamicin

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

Intervention Type DRUG

Other Intervention Names

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BACIDAL GENTREX

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Silpakorn University

OTHER

Sponsor Role collaborator

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ittaprach Yimsuk, PharmD

Role: STUDY_CHAIR

College of Pharmacy, Rangsit university

Pamila Tasanavipas, MD

Role: STUDY_DIRECTOR

Phramongkutklao hospital and College of Medicine

Daraporn Rungprai, BCP

Role: STUDY_DIRECTOR

Faculty of Pharmacy, Silpakorn University

Wichai Santimaleeworagun, BCP

Role: STUDY_DIRECTOR

Faculty of Pharmacy, Silpakorn University

Kulthida Chaijumroen, B.N.S.

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao hospital and College of Medicine

Locations

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Phramongkutklao Hospital

Ratchathewi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Ittaprach Yimsuk, PharmD

Role: CONTACT

097-237-4797

Pamila Tasanavipas, MD

Role: CONTACT

081-344-2383

Facility Contacts

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Ittaprach Yimsuk, PharmD

Role: primary

097-237-4797

Pamila Tasanavipas, MD

Role: backup

081-344-2383

Other Identifiers

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PDRI-2021

Identifier Type: -

Identifier Source: org_study_id

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