- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00438269
Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection
Appropriate Antimicrobial Therapy in Critical Care: A Pilot Randomized Controlled Trial
Infection developing in the intensive care unit is a common complication of critical illness, but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests usually is not possible for at least two days. It is unclear what the optimal management approach should be while awaiting the results of diagnostic tests. In some circumstances, broad spectrum antibiotics are started with a plan to adjust them once the results of cultures are available. Observational studies show that this results in greater antibiotic use, and the risk of superinfection and resistance. In other circumstances, antibiotics may be withheld pending the results of cultures, a strategy that leads to a delay in therapy when cultures are positive, and that may be associated with a worse clinical outcome.
We undertook a randomized pilot study to address the question: "In a critically ill patient for whom clinicians are uncertain whether infection may be present, and in whom potential sites of infection have been managed by removing or changing invasive devices, can a policy of delaying antibiotic treatment until cultures are available reduce the risks of excessive antibiotic use, without increasing the risks associated with delayed therapy?"
Recognizing that the question has not been formally addressed before, and that approaches to clinical management are both widely divergent and passionately held, our pilot study tested the feasibility and acceptability of undertaking a larger trial with sufficient power to determine equivalence.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
We randomized critically ill patients who had been in hospital for at least 72 hours, and in the ICU for at least 24 hours, and who manifested either a temperature >38.5 degrees, or a temperature>38.0 degrees and a white cell count >12,000, and in whom clinicians entertained the possibility of infection as a diagnosis, to either site-specific broad spectrum empiric antibiotics or the corresponding placebo. All patients underwent a comprehensive series of investigations to identify an infectious focus, and all patients had full source control, including changes of central lines and urinary catheters, and change of nasogastric to orogastric tubes.
Patients were maintained in assigned study arm for seven days, or until culture data were available, at which time they were switched to culture-guided narrow spectrum therapy
Studientyp
Einschreibung
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 2C4
- University Health Network
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- In hospital > 72 hrs and in ICU > 24hrs, and
- Core temperature ≥38.5°C, or temperature ≥ 38.0°C with a WBC>12,000/mm3, or temperature ≤ 36.0°C with a WBC > 12,000/mm3
- Suspicion of infection
Exclusion Criteria:
- Age < 18 years
- Imminent death (within 24 hrs) or withdrawal of aggressive therapy
- Prosthetic heart valve or vascular graft
- Neutropenia (Absolute neutrophil count < 1000/mm3)
- Received > 16 hours of a broad spectrum antibiotic in the last 24 hours (3rd gen cephalosporin, fluoroquinolone, carbapenem, anti-pseudomonal penicillin) or any combination therapy
- History of allergic reaction to both study medications
New physical findings consistent with infection:
- Meningeal signs
- Peritonitis + free air on Abdo x-ray
- Soft tissue infection / cellulitis
- Murmur & suspicion of endocarditis
- Newly available (within past 24 hours) culture results consistent with infection
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
---|
Feasibility: = % of eligible patients who were consented and randomized
|
Acceptability: = % of patients in each study arm who were switched to open label therapy prior to culture results
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
---|
ICU-free days
|
Mortality (14, 30, 90 day)
|
Microbial resistance patterns
|
Antibiotic-free days
|
Change in organ dysfunction (MOD scores)
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Mary-Anne W Aarts, MD MSc, University of Toronto
- Hauptermittler: John C Marshall, MD, University of Toronto
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Entzündung
- Krankheitsattribute
- Iatrogene Krankheit
- Schock
- Änderungen der Körpertemperatur
- Infektionen
- Kritische Krankheit
- Fieber
- Systemisches Entzündungsreaktionssyndrom
- Kreuzinfektion
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Antibakterielle Mittel
- Cytochrom-P-450-Enzym-Inhibitoren
- Antiprotozoenmittel
- Antiparasitäre Mittel
- Cytochrom P-450 CYP1A2-Inhibitoren
- Beta-Lactamase-Hemmer
- Metronidazol
- Ciprofloxacin
- Cefazolin
- Meropenem
- Piperacillin
- Tazobactam
- Piperacillin, Tazobactam-Medikamentenkombination
Andere Studien-ID-Nummern
- AATICC Pilot Study
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .