Clinical trial NCT05251584: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peritoneal Dialysis-related Infection
Keywords: Peritoneal dialysis-related infection
Infectious peritonitis
Exit-site infection
Infection rate
Drug susceptibility
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
Collaborators: name: Silpakorn University
First posted: 2022-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group: topical mupirocin ointment retrospective period compare with gentamicin prospective period
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Rate of Exit-site infection in mupirocin compared with gentamicin group
timeFrame: 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.
measure: Rate of Infectious peritonitis in mupirocin compared with gentamicin group
timeFrame: 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:
measure: Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
timeFrame: 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.
measure: Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group
timeFrame: 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.
measure: Percentage of catheter removal due to peritoneal dialysis-related infection
timeFrame: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
measure: Time to first peritoneal dialysis-related infection after gentamicin application
timeFrame: Prospective period at least 1 year after entry to the study.
measure: Drug susceptibility of causative pathogens of peritoneal dialysis-related infection
timeFrame: Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
state: Bangkok
Study officials:
affiliation: College of Pharmacy, Rangsit university
name: Ittaprach Yimsuk, PharmD
role: STUDY_CHAIR
affiliation: Phramongkutklao hospital and College of Medicine
name: Pamila Tasanavipas, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Silpakorn University
name: Daraporn Rungprai, BCP
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Silpakorn University
name: Wichai Santimaleeworagun, BCP
role: STUDY_DIRECTOR
affiliation: Phramongkutklao hospital and College of Medicine
name: Kulthida Chaijumroen, B.N.S.
role: PRINCIPAL_INVESTIGATOR
References: