Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With cUTI, cIAI,NP Including VAP

NCT ID: NCT02364284

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study

Detailed Description

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This will be an observational, historical cohort study from medical chart review of adult hospitalized patients for each of the three conditions of interest (complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP)). For this study, the proposed patient selection period extends for 12 months, from July 1, 2013 to June 30, 2014. Patients selected during this period will be followed from diagnosis (i.e., diagnosis of cUTI, cIAI or NP) until symptom resolution, discharge or 30-days post discharge \[based on data availability to assess readmission and outpatient visits\], death while hospitalized, loss to follow-up or the end of study period if not yet discharged from index hospitalization \[December 31, 2014\]).

Conditions

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Urinary Tract Infection (cUTI) Intra-abdominal Infection (cIAI) and Nosocomial Pneumonia (NP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Urinary Tract Infection (cUTI)

Patients ≥18 years with diagnosis of urinary tract infection.

No interventions assigned to this group

Intra Abdominal Infection(cIAI)

Patients ≥ 18 years with diagnosis of Intra Abdominal Infection

No interventions assigned to this group

Nosocomial Pneumonia (NP)

Patients ≥ 18 years with diagnosis of Hospital acquired pneumonia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

ICF to be obtained (refer slides 26-30) Adult (≥18 years) patients Patients with a diagnosis of at least one of the three conditions hospitalised during the period July 1, 2013 to June 30, 2014 Hospital acquired or healthcare associated cUTI Hospital acquired or healthcare associated cIAI NP including VAP

Exclusion Criteria

The patient participated in a clinical trial during the patient selection period (01-Jul-2013 to 30-Jun-2014) or during the follow-up period\* For patients diagnosed with cUTI: The patient has a diagnosis of hospital acquired or healthcare associated cUTI with concomitant presence of Fungal UTI with colony count \> 10\^3/mL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Laure Fedou

Role: PRINCIPAL_INVESTIGATOR

CHU de Limoges - Hôpital Dupuytren

Locations

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Research Site

Belo Horizonte, , Brazil

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Campinas, , Brazil

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Porto Alegre, , Brazil

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Argenteuil, , France

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Bordeaux, , France

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Créteil, , France

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Limoges, , France

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Lyon, , France

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Nantes, , France

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Athens, , Greece

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Heraklion, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Bologna, , Italy

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Brescia, , Italy

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Monza, , Italy

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Roma, , Italy

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Vicenza, , Italy

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Moscow, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Sestroretsk, Saint Petersburg, , Russia

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Badalona, , Spain

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Barcelona, , Spain

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Oviedo, , Spain

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Seville, , Spain

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Terrassa, , Spain

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Countries

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Brazil France Greece Italy Russia Spain

References

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Ryan K, Karve S, Peeters P, Baelen E, Potter D, Rojas-Farreras S, Pascual E, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in healthcare-associated or nosocomial pneumonia. J Infect. 2018 Jul;77(1):9-17. doi: 10.1016/j.jinf.2018.04.002. Epub 2018 May 6.

Reference Type DERIVED
PMID: 29742471 (View on PubMed)

Karve S, Ryan K, Peeters P, Baelen E, Rojas-Farreras S, Potter D, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in patients with complicated urinary tract infection. J Infect. 2018 Feb;76(2):121-131. doi: 10.1016/j.jinf.2017.11.001. Epub 2017 Nov 8.

Reference Type DERIVED
PMID: 29128389 (View on PubMed)

Related Links

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Other Identifiers

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D4280R00005

Identifier Type: -

Identifier Source: org_study_id

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