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

13. februar 2022 opdateret af: Phramongkutklao College of Medicine and Hospital

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Rekruttering
        • Phramongkutklao Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Ittaprach Yimsuk, PharmD
        • Ledende efterforsker:
          • Pamila Tasanavipas, MD
        • Ledende efterforsker:
          • Daraporn Rungprai, BCP
        • Underforsker:
          • Wichai Santimaleeworagun, BCP
        • Underforsker:
          • Kulthida Chaijumroen, B.N.S.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Mupirocin
Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021
Andre navne:
  • BACIDAL
Medicin: Gentamicin
Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022
Andre navne:
  • GENTREX

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Exit-site infection in mupirocin compared with gentamicin group
Tidsramme: 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.
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
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group
Tidsramme: 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.
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in 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
Tidsramme: 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.
Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in 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
Tidsramme: Retrospective 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
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
Tidsramme: Prospective 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
Prospective period at least 1 year after entry to the study.
Drug susceptibility of causative pathogens of peritoneal dialysis-related infection
Tidsramme: Retrospective 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
Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Phramongkutklao College of Medicine and Hospital

Samarbejdspartnere

Silpakorn University

Efterforskere

  • Studieleder: Daraporn Rungprai, BCP, Faculty of Pharmacy, Silpakorn University
  • Studiestol: Ittaprach Yimsuk, PharmD, College of Pharmacy, Rangsit university
  • Studieleder: Pamila Tasanavipas, MD, Phramongkutklao Hospital and College of Medicine
  • Studieleder: Wichai Santimaleeworagun, BCP, Faculty of Pharmacy, Silpakorn University
  • Ledende efterforsker: Kulthida Chaijumroen, B.N.S., Phramongkutklao Hospital and College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2021

Primær færdiggørelse (Forventet)

31. marts 2023

Studieafslutning (Forventet)

31. maj 2023

Datoer for studieregistrering

Først indsendt

4. januar 2022

Først indsendt, der opfyldte QC-kriterier

13. februar 2022

Først opslået (Faktiske)

22. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PDRI-2021

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