- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00472667
PROcalcitonin Reduce Antibiotic Treatments in Acute-Ill Patients (PRORATA) (PRORATA)
24. november 2008 opdateret af: Assistance Publique - Hôpitaux de Paris
Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Clinical and laboratory signs are neither specific nor sensitive for diagnosis of sepsis in critically-ill patients.
Because delaying antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU -patients, even when they are not needed.
In addition, only few well-designed studies concerning the duration of antibiotic treatment have been so far published.
Consequently, many patients received antibiotics during the ICU stay.
Many studies have shown that exposure to antibiotics, the so called "selection pressure" is an independent risk factor for acquisition of resistance in individual patients.
Therefore, reducing antibiotic use is probably necessary to control antibiotic resistance.
Many clinical studies have shown that procalcitonin (PCT) is able to distinguish the inflammatory response to infection from other types of inflammation and to distinguish bacterial from viral infections.
Recent studies have shown that PCT guidance substantially and safely reduced antibiotic overuse in patients with lower respiratory tract infections.
We aimed to evaluate the role of PCT in reducing the use of antibiotics in ICU adult patients.
The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
630
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Paris, Frankrig, 75018
- Chu Bichat Claude Bernard
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patient hospitalised in the ICU
- Bacterial infection suspected
- At ICU admission the patient do not receive antibiotics or receive antibiotics for less than 24hours and an interval between admission and inclusion < 12 hours
- During ICU stay, provided that the interval between the start of suspected infection and inclusion is < 12hours
- Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Patient expected to remain hospitalised in the ICU for less than 3 days
- Neutropenia
- Infection or presumed infection requiring prolonged antibiotic therapy (endocarditis,osteo-articular infection, mediastinitis, deep abscess, tuberculosis, pneumocystis pneumonia, toxoplasmosis).
- Simplified Acute Physiology Score II at ICU admission (calculated during the first 12h)
- Attending physician declining to use full life support.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Procalcitonin guided strategy
|
Procalcitonin guided strategy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Exposition to antibiotics, defined by antibiotic-free days
Tidsramme: assessed 28 days after inclusion
|
assessed 28 days after inclusion
|
Mortality
Tidsramme: at Day 28 and Day 60
|
at Day 28 and Day 60
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days
Tidsramme: between D1 and D28
|
between D1 and D28
|
The length of ICU and hospital stay
Tidsramme: during the stay at the hospital
|
during the stay at the hospital
|
The evolution of SOFA score parameters
Tidsramme: between D1 and D28
|
between D1 and D28
|
The number of mechanical ventilation-free days
Tidsramme: at D28
|
at D28
|
The acquisition cost of antibiotics
Tidsramme: between D1 and D28
|
between D1 and D28
|
The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples.
Tidsramme: between D1 and D28
|
between D1 and D28
|
The percentages of relapses of infection
Tidsramme: between D1 and D28
|
between D1 and D28
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lila BOUADMA, MD, Assistance Publique - Hôpitaux de Paris
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. juli 2007
Primær færdiggørelse (Faktiske)
1. maj 2008
Studieafslutning (Faktiske)
1. maj 2008
Datoer for studieregistrering
Først indsendt
11. maj 2007
Først indsendt, der opfyldte QC-kriterier
11. maj 2007
Først opslået (Skøn)
14. maj 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. november 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. november 2008
Sidst verificeret
1. maj 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P060204
- AOR06019
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 .
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