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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02364284 |
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Date of registration:
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06/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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. |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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1322 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02364284 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Brazil
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France
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Greece
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Italy
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Russian Federation
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Spain
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Contacts
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Name:
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Anne-Laure Fedou |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Limoges - Hôpital Dupuytren |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Intra-abdominal Infection (cIAI) and
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Nosocomial Pneumonia (NP)
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Urinary Tract Infection (cUTI)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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]
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Secondary ID(s)
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D4280R00005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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