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

13. februar 2022 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Rekruttering
        • Phramongkutklao Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ittaprach Yimsuk, PharmD
        • Hovedetterforsker:
          • Pamila Tasanavipas, MD
        • Hovedetterforsker:
          • Daraporn Rungprai, BCP
        • Underetterforsker:
          • Wichai Santimaleeworagun, BCP
        • Underetterforsker:
          • Kulthida Chaijumroen, B.N.S.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Mupirocin
Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021
Andre navn:
  • BACIDAL
Legemiddel: Gentamicin
Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022
Andre navn:
  • GENTREX

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Phramongkutklao College of Medicine and Hospital

Samarbeidspartnere

Silpakorn University

Etterforskere

  • 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
  • Hovedetterforsker: Kulthida Chaijumroen, B.N.S., Phramongkutklao hospital and College of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2021

Primær fullføring (Forventet)

31. mars 2023

Studiet fullført (Forventet)

31. mai 2023

Datoer for studieregistrering

Først innsendt

4. januar 2022

Først innsendt som oppfylte QC-kriteriene

13. februar 2022

Først lagt ut (Faktiske)

22. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. februar 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PDRI-2021

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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