- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05171257
Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit (RESTART)
Quantifying Gram-negative Resistance to Empiric Therapy in the Intensive Care Unit - Repeat ExpoSure to AntimicRobial Therapy (RESTART)
Antimicrobial resistance is a global health emergency estimated to be responsible for 700,000 deaths per year worldwide, and it is well known that previous antibiotic exposure is the single most contributing factor. For example, the use of non-antipseudomonal agents can increase risk for any P. aeruginosa strain; however, the use of an agent with antipseudomonal activity would select for resistance to that particular antimicrobial agent or class. Demonstrated that each additional day of exposure to any antipseudomonal beta-lactam is associated with an increased risk of new resistance development.
The study seeks to determine whether the choice of empiric therapy (i.e., the same agent versus a different agent from prior antibiotic exposure) has any effect on the likelihood of in vitro activity against GN pathogens (GNPs) in a subsequent infection.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Antimicrobials are the most commonly prescribed drugs in medicine, resulting in inappropriate use in approximately 50% of cases Misuse can have devastating effects through resistance development which further complicates selection of appropriate empiric antibiotics. In cases of severe illness, it is easy for clinicians to rely on broad spectrum antibiotics to cover the majority of likely pathogens when dealing with a presumed bacterial infection. However, this practice perpetuates the cycle of resistance. Inappropriate empiric therapy is associated with worse outcomes in resistant Gram-negative (GN) bacteremia and pneumonia, so clinicians should strive for targeted coverage that is specific to the pathogen of interest when possible. Johnson et al. showed that patients with recent antibiotic exposure had greater inappropriate initial antimicrobial therapy (45.4% vs. 21.2%; p < 0.001) and higher in-hospital mortality (51.3% vs. 34.0%; p < 0.001) compared with patients without recent antibiotic exposure.
The 2020 Infectious Diseases Society of America (IDSA) Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections reports an increased risk of resistance with antibiotic exposure in the past 30 days. Additionally, expert opinion prompts consideration of empiric coverage with a GN agent from a different class that offers comparable spectrum of activity from previous exposure. The 2019 Community-acquired Pneumonia (CAP) Guidelines from the American Thoracic Society and IDSA lists prior antibiotic use in the last 90 days as a risk factor for P. aeruginosa.The 2016 Hospital-acquired and Ventilator-associated Pneumonia (HAP, VAP) Guidelines from IDSA, list antibiotic use in the past 90 days as a risk factor for P. aeruginosa and other GN organisms in HAP. Additionally, antibiotic use in the past 90 days is listed as having an association with increased risk of multi-drug resistant VAP. The CAP, HAP, and VAP Guidelines do not mention using the same versus different agent as empiric choice if previous antibiotic exposure is to an anti-pseudomonal agent.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75203
- Methodist Dallas Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- ≥18 years of age
- GNP pneumonia or bacteremia during hospital admission
- Previous IV antibiotics for at least 48 hours in the past 90 days
- Culture MIC data available
Exclusion Criteria:
- Patients with a history of isolate resistance in the previous six months to antibiotics being studied
- Patients that received antibiotics within five days prior to study inclusion
- Patients on more than one anti-pseudomonal beta-lactam antibiotics (excluding emergency department doses) during previous exposure
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
repeat group
patients receiving empiric therapy with the same IV antibiotics from prior
|
patients receiving same IV antibiotic treatment from prior
|
change group
patients receiving differing IV antibiotics from prior
|
patients receiving differing IV antibiotics from prior
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rates of resistance
Tidsramme: charts from 4/1/2017 to 3/31/2021
|
Rates of resistance in patients receiving empiric therapy with the same IV antibiotics from prior (repeat group) compared to rates of resistance in patients receiving differing IV antibiotics from prior (change group)
|
charts from 4/1/2017 to 3/31/2021
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intensive Care Unite LOS(ICU LOS)
Tidsramme: charts from 4/1/2017 to 3/31/2021
|
Intensive Care Unite LOS(ICU LOS)
|
charts from 4/1/2017 to 3/31/2021
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mathew Crotty, MD, Methodist
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 038.PHA.2021.D
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 Gram-negative bakterielle infektioner
-
Assistance Publique - Hôpitaux de ParisAfsluttetMikrobiel epidemiologi og klorhexidinfølsomhed ved orofaryngeal og intestinal kolonisering (OroColi)Oropharyngeal Gram-negativ Bacilli koloniseringFrankrig
-
Assistance Publique - Hôpitaux de ParisAfsluttetOropharyngeal Gram-negativ Bacilli koloniseringFrankrig
-
University of PittsburghAfsluttetGram negativ infektionForenede Stater
-
Seoul National University HospitalAfsluttetMultiresistent Gram-negativ bakterieinfektionKorea, Republikken
-
ShionogiRekrutteringGram-negative bakterielle infektioner | Kompliceret urinvejsinfektion (cUTI) | Hospital Acquired Bacterial Pneumonia (HABP) | Ventilator Associated Bacterial Pneumonia (VABP)Forenede Stater, Australien, Grækenland, Litauen, Mexico, Filippinerne, Spanien, Ukraine, Panama
-
PfizerAllerganAfsluttetGram-negativ bakteriel infektionForenede Stater, Ungarn, Slovakiet, Taiwan, Indien, Estland, Grækenland, Italien
-
PfizerAfsluttetGram-negativ bakteriel infektionAustralien
-
ShionogiAfsluttetGram-negativ infektionSpanien
-
Osijek University HospitalAfsluttetSepsis | Gram-negativ Bakteriæmi | Gram-positiv bakteriemiKroatien
-
Ohio State UniversityAgency for Healthcare Research and Quality (AHRQ)RekrutteringHealthcare Associated Infection | Clostridioides Difficile-infektionForenede Stater