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

September 1, 2017 updated by: Pfizer

Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With Complicated Urinary Tract Infection,Complicated Intra-abdominal Infection and Nosocomial Pneumonia Including Ventilator-associated Pneumonia.

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

Study Overview

Status

Completed

Conditions

Detailed Description

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]).

Study Type

Observational

Enrollment (Actual)

1322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
        • Research Site
      • Campinas, Brazil
        • Research Site
      • Porto Alegre, Brazil
        • Research Site
  • France
      • Argenteuil, France
        • Research Site
      • Bordeaux Cedex, France
        • Research Site
      • Creteil cedex, France
        • Research Site
      • Limoges cedex, France
        • Research Site
      • Lyon Cedex 03, France
        • Research Site
      • Nantes Cedex 1, France
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Heraklion, Greece
        • Research Site
      • Patras, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Italy
      • Bologna, Italy
        • Research Site
      • Brescia, Italy
        • Research Site
      • Monza, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Vicenza, Italy
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Saint-Petersburg, Russian Federation
        • Research Site
      • Sestroretsk, St. Petersburg, Russian Federation
        • Research Site
  • Spain
      • Badalona, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Terrassa, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult (≥18 years) patients. Hospitalized patients with a diagnosis of at least one of the following three conditions during the period July 1, 2013 to June 30, 2014 should be included in this study.

Hospital acquired or healthcare associated cUTI Hospital acquired or healthcare associated cIAI NP including VAP

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Urinary Tract Infection (cUTI)
Patients ≥18 years with diagnosis of urinary tract infection.
Intra Abdominal Infection(cIAI)
Patients ≥ 18 years with diagnosis of Intra Abdominal Infection
Nosocomial Pneumonia (NP)
Patients ≥ 18 years with diagnosis of Hospital acquired pneumonia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe antibiotic management and document treatment outcome among hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
Time Frame: 12 months
Evaluate failure or success of the initial antibiotic treatment following cUTI, cIAI and NP diagnosis. Initial antibiotic therapy is defined as all antibiotic agents received during the 48 hours post initiation of antibiotic therapy - The primary outcome measure will be assessed from the antibiotic initiation date until end of follow-up defined by in-hospital with symptom resolution, in-hospital without symptom resolution, discharged to home, discharged to other health care facility, readmission within 30 days for same infection, readmission within 30 days post discharge with other diagnosis, death during hospital stay, death post discharge within 30 days.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify potential risk factors related to outcomes of initial antibiotic treatment of hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
Time Frame: 12 months
Assess risk factors related to the primary outcome measure. Covariates considered in the risk assessment will include: site characteristics, patient characteristics, secondary infections, prior medical history and comorbidity burden, hospitalization characteristics, pathogen characteristics, co-medications - The listed covariates will be assessed at baseline (i.e., at index hospitalization date), during the hospital stay and the 30-day period post discharge date.
12 months
To describe healthcare utilization and costs associated with hospital acquired or healthcare associated cUTI, cIAI and NP initial antibiotic treatment outcome
Time Frame: 12 months
Assess health care utilization among patients with cUTI, cIAI and NP. Variables assessed to address this will include - hospital length of stay, ICU length of stay, number of surgical procedures, number of outpatient visits, days on antibiotic therapy, number of readmission during follow-up - The listed measures will be assessed during the hospital stay and during the 30-day period post discharge date.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Principal Investigator: Anne-Laure Fedou, Chu de Limoges - Hopital Dupuytren

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4280R00005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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