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Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom

25 marzo 2014 aggiornato da: Pfizer

A Study To Describe The Early Clinical Experience With Anidulafungin In Patients With Liver Disease At King's College Hospital NHS Trust, London

The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

50

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
      • London, Regno Unito, SE5 9RS
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.

Descrizione

Inclusion Criteria:

  • Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th September 2010.

Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period

Exclusion Criteria:

  • Patients who participated in any interventional clinical trial during this episode of sepsis.

Patients who received anidulafungin for infection prophylaxis

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Anidulafungin
Droga: anidulafungin
A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Altri nomi:
  • ECALTA, ERAXIS

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Favorable Outcome
Lasso di tempo: Day 28 post-treatment
Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Day 28 post-treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Unfavorable Outcome
Lasso di tempo: Day 28 post-treatment
Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.
Day 28 post-treatment
Percentage of Participants Who Died Due to All Causes
Lasso di tempo: Baseline up to Day 28 post-treatment
Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.
Baseline up to Day 28 post-treatment
Percentage of Participants With Death Attributable to Fungal Infection
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Percentage of Participants With Death Unrelated to Fungal Infection
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Percentage of Participants With Favorable Clinical Response
Lasso di tempo: Day 28 post-treatment
Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Day 28 post-treatment
Percentage of Participants With Lack of Clinical Response
Lasso di tempo: Day 28 post-treatment
Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Day 28 post-treatment
Percentage of Participants Requiring Change or Additional Antifungal Therapy
Lasso di tempo: Baseline up to Day 28 post-treatment
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Baseline up to Day 28 post-treatment
Percentage of Participants With Oral Antifungal Started to Complete Therapy
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Percentage of Participants With Documented Eradication of Infecting Species
Lasso di tempo: Baseline
Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.
Baseline
Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results
Lasso di tempo: Baseline up to Day 28 post-treatment
An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Baseline up to Day 28 post-treatment
Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results
Lasso di tempo: Baseline up to Day 28 post-treatment
A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Baseline up to Day 28 post-treatment
Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy
Lasso di tempo: Baseline
Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).
Baseline
Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy
Lasso di tempo: Day 28 post-treatment
Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.
Day 28 post-treatment
Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy
Lasso di tempo: Baseline up to Day 28 post-treatment
Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.
Baseline up to Day 28 post-treatment
Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
Lasso di tempo: Baseline
Baseline
Duration of Stay at Liver Intensive Therapy Unit (LITU)
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3
Lasso di tempo: Baseline
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).
Baseline
Percentage of Participants With Concomitant Bacterial or Viral Infection
Lasso di tempo: Baseline
Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).
Baseline
Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Lasso di tempo: Baseline
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Baseline
Dose Changes for Immunosuppressant Drugs
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
Lasso di tempo: Baseline
Baseline
Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy
Lasso di tempo: Baseline
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).
Baseline
Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy
Lasso di tempo: Baseline
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Baseline
Number of Participants With Infection Sites as Per Microbiological Analysis
Lasso di tempo: Baseline
Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.
Baseline
Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan
Lasso di tempo: Baseline
Baseline
Infecting Organisms by Species
Lasso di tempo: Baseline up to Day 14 post-treatment
Baseline up to Day 14 post-treatment
Percentage of Participants With Prior Colonization With Candida by Species
Lasso di tempo: Baseline
Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Baseline
Percentage of Participants With Prior Colonization With Candida by Colonization Index
Lasso di tempo: Baseline
Baseline
Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Lasso di tempo: Baseline
Baseline
Number of Participants Who Received Water-based and Ethanol-based Formulation
Lasso di tempo: Baseline
Baseline
Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Lasso di tempo: Baseline
Baseline
Percentage of Participants Who Received 200 mg Loading Dose
Lasso di tempo: Day 1
Day 1
Percentage of Participants Who Received 100 mg Dose on Day 2
Lasso di tempo: Day 2
Day 2
Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Number of Participants With Other Dosing Patterns
Lasso di tempo: Baseline up to Day 28 post-treatment
The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.
Baseline up to Day 28 post-treatment
Duration of Anidulafungin Therapy
Lasso di tempo: Baseline
Baseline
Number of Serious Adverse Events (SAEs)
Lasso di tempo: Baseline up to Day 28 post-treatment
Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Baseline up to Day 28 post-treatment
Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment
Number of Participants With Different Types of Drug-related Serious Adverse Events
Lasso di tempo: Baseline up to Day 28 post-treatment
Baseline up to Day 28 post-treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2011

Completamento primario (Effettivo)

1 maggio 2011

Completamento dello studio (Effettivo)

1 maggio 2011

Date di iscrizione allo studio

Primo inviato

13 settembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

13 settembre 2010

Primo Inserito (Stima)

15 settembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 aprile 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 marzo 2014

Ultimo verificato

1 marzo 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A8851028

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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