French Study In ICU Patients Treated With Tigecycline
15 novembre 2011 aggiornato da: Wyeth is now a wholly owned subsidiary of Pfizer
French Prospective Observational Study In Intensive Care Unit (ICU) Patients Treated With Tigecycline
This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned.
Data will be collected only from subjects providing informed consent.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Healthcare visit.
Extension Rationale:
In order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of Basic Results due 26-May-2011 for protocol 3074A1-4448 (B1811030), NCT00799591. Our proposed submission date is 14-Sept-2011.
Pfizer acquired Wyeth on October 16, 2009. With regard to this study, our reconciliation of data identified some discrepancies in data listed in the Project database (managed by the CRO) and the Safety Database (managed by Pfizer). We are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. We are requesting this extension to complete that work so that the data can be treated as final and the CSR can be completed.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
156
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
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Paris, Francia, 75018
- Pfizer Investigational Site
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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
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Intensive Care Unit
Descrizione
Inclusion Criteria:
- Adult men and women (18 years).
- Subjects hospitalized in a medical or surgical intensive care unit (ICU) (on the day of enrolment in the study).
- Subjects treated with tigecycline (first, second or third line), said treatment freely chosen by the participating physician, prior to enrollment in the study.
Exclusion Criteria:
- Subjects participating in another biomedical research study.
- Patient (or legal representative) who has not dated or signed informed consent document.
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
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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1
Intensive Care
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Observational study so no intervention in the patient.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
Lasso di tempo: End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event.
Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
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End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit
Lasso di tempo: Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event.
Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
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Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
Lasso di tempo: Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.
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Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Mean Duration (Days) of Treatment With Tigecycline
Lasso di tempo: Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Baseline (Inclusion) through last dose of study treatment or up to 25 months
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Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT
Lasso di tempo: Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Combinations of antibiotic treatments for participants treated with clinical success with tigecycline.
Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
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Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months
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Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit
Lasso di tempo: Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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Combinations of antibiotic treatments for participants treated with clinical success with tigecycline.
Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
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Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
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Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture
Lasso di tempo: Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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Microbiological sampling results categorized as a positive blood culture (presence of infection).
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Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination
Lasso di tempo: Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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Microbiological sampling results categorized according to direct examination (identification of the class of germs).
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Post-baseline (Day 1) through last dose of study treatment or up to 25 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
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.
Pubblicazioni generali
- Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140.
- Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143.
- Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141.
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 settembre 2008
Completamento primario (Effettivo)
1 maggio 2010
Completamento dello studio (Effettivo)
1 maggio 2010
Date di iscrizione allo studio
Primo inviato
26 novembre 2008
Primo inviato che soddisfa i criteri di controllo qualità
28 novembre 2008
Primo Inserito (Stima)
1 dicembre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
19 dicembre 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 novembre 2011
Ultimo verificato
1 settembre 2011
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 3074A1-4448
- B1811030
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
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 .
Prove cliniche su Observational study so no intervention in the patient.
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IRCCS San RaffaeleAttivo, non reclutanteCarcinoma polmonare non a piccole cellule | Carenza di ricombinazione omologa | Inibitore PARP | EGFRItalia