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Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia

11. marts 2021 opdateret af: National Taiwan University Hospital

Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria

There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

49

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

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

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients in medical intensive care unit with ventilator use

Beskrivelse

Inclusion Criteria:

  1. age ≥ 20 years old
  2. medical ICU patients with invasive ventilator use ≥ 48 hours
  3. multidrug resistant Gram-negative bacteria obtained from lower respiratory tract

Exclusion Criteria:

  1. pregnancy
  2. concurrent use of other antimicrobial agents active for isolated multidrug resistant Gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam
  3. patients who refuse to receive any inhaled therapy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Colistimethate sodium inhalation

Colistimethate sodium inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.

Additional intravenous colistimethate sodium for patients with ventilator-associated pneumonia
saline inhalation
saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
clinical cure rate
Tidsramme: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
including clinical improvement and microbiological outcome(eradication of the pathogen as no growth of the pathogen in the final culture of specimens during the entire hospitalization)
From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days

Sekundære resultatmål

Resultatmål
Tidsramme
intensive care unit stay
Tidsramme: From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
hospital stay
Tidsramme: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
all cause mortality
Tidsramme: From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
ventilator-associated pneumonia-related mortality
Tidsramme: Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days
Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days
microbiologic eradication in colonization patients
Tidsramme: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
ventilator-associated pneumonia rate
Tidsramme: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

National Taiwan University Hospital

Efterforskere

  • Ledende efterforsker: Wang-Huei Sheng, M.D. Ph.D, Center of Infection Control of National University Hospital

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

1. oktober 2013

Primær færdiggørelse (Faktiske)

4. februar 2016

Studieafslutning (Faktiske)

31. august 2017

Datoer for studieregistrering

Først indsendt

22. oktober 2013

Først indsendt, der opfyldte QC-kriterier

28. oktober 2013

Først opslået (Skøn)

3. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2021

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201303119MINB

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ventilator Associated Pneumonia

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner