Clinical trial NCT02364284: Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With cUTI, cIAI,NP Including VAP
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection (cUTI)
Intra-abdominal Infection (cIAI) and
Nosocomial Pneumonia (NP)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 1322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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

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 \[December 31, 2014\]).

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

Primary outcomes:
measure: To describe antibiotic management and document treatment outcome among hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: To describe healthcare utilization and costs associated with hospital acquired or healthcare associated cUTI, cIAI and NP initial antibiotic treatment outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Campinas
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Argenteuil
country: France
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Creteil cedex
country: France
facility: Research Site
city: Limoges cedex
country: France
facility: Research Site
city: Lyon Cedex 03
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Patras
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Monza
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Vicenza
country: Italy
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Sestroretsk, St. Petersburg
country: Russian Federation
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Terrassa
country: Spain
facility: Research Site
Study officials:
affiliation: CHU de Limoges - Hôpital Dupuytren
name: Anne-Laure Fedou
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.