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

Last updated on November 14, 2019

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Study Location
Research Site
Belo Horizonte, , Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urinary Tract Infection (cUTI), Intra-abdominal Infection (cIAI) and, Nosocomial Pneumonia (NP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT02364284
Pfizer
Completed
Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With cUTI, cIAI,NP Including VAP

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Descriptive Information
Brief TitleReporting Patterns and Results of Initial Antibiotic Treatment in Patients With cUTI, cIAI,NP Including VAP
Official TitleReporting 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.
Brief SummaryReporting 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 DescriptionThis 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 TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-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

Condition
  • Urinary Tract Infection (cUTI)
  • Intra-abdominal Infection (cIAI) and
  • Nosocomial Pneumonia (NP)
InterventionNot Provided
Study Groups/Cohorts
  • 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
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: November 29, 2016)
1322
Original Estimated Enrollment
 (submitted: February 17, 2015)
2160
Actual Study Completion DateFebruary 2016
Actual Primary Completion DateFebruary 2016   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesBrazil,   France,   Greece,   Italy,   Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02364284
Other Study ID NumbersD4280R00005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Principal Investigator:Anne-Laure FedouCHU de Limoges - Hôpital Dupuytren
PRS AccountPfizer
Verification DateSeptember 2017

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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