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

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ClinicalTrials.gov Identifier: NCT02364284
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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

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

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]).

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Study Type : Observational
Actual Enrollment : 1322 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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.
Study Start Date : February 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364284


Locations
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Brazil
Research Site
Belo Horizonte, Brazil
Research Site
Campinas, Brazil
Research Site
Porto Alegre, Brazil
France
Research Site
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
Greece
Research Site
Athens, Greece
Research Site
Heraklion, Greece
Research Site
Patras, Greece
Research Site
Thessaloniki, Greece
Italy
Research Site
Bologna, Italy
Research Site
Brescia, Italy
Research Site
Monza, Italy
Research Site
Roma, Italy
Research Site
Vicenza, Italy
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Novosibirsk, Russian Federation
Research Site
Saint-Petersburg, Russian Federation
Research Site
Sestroretsk, St. Petersburg, Russian Federation
Spain
Research Site
Badalona, Spain
Research Site
Barcelona, Spain
Research Site
Oviedo, Spain
Research Site
Sevilla, Spain
Research Site
Terrassa, Spain
Sponsors and Collaborators
Pfizer
Investigators
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Principal Investigator: Anne-Laure Fedou CHU de Limoges - Hôpital Dupuytren

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02364284     History of Changes
Other Study ID Numbers: D4280R00005
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Pneumonia
Urinary Tract Infections
Intraabdominal Infections
Healthcare-Associated Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents