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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05251584
Enrollment
60
Registered
2022-02-22
Start date
2021-12-01
Completion date
2023-05-31
Last updated
2022-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis-related Infection

Keywords

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

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.

Interventions

DRUGGentamicin

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

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

Sponsors

Silpakorn University
CollaboratorOTHER
Phramongkutklao College of Medicine and Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Exit-site infection in mupirocin compared with gentamicin groupAll 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.
Rate of Infectious peritonitis in mupirocin compared with gentamicin groupAll 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

Secondary

MeasureTime frameDescription
Percentage of catheter removal due to peritoneal dialysis-related infectionRetrospective 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
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin groupAll 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
Drug susceptibility of causative pathogens of peritoneal dialysis-related infectionRetrospective 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
Time to first peritoneal dialysis-related infection after gentamicin applicationProspective 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
Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin groupAll 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

Countries

Thailand

Contacts

Primary ContactIttaprach Yimsuk, PharmD
ittaprach.y@gmail.com097-237-4797
Backup ContactPamila Tasanavipas, MD
pa_tass@hotmail.com081-344-2383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026