Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With cUTI, cIAI,NP Including VAP
RECOMMEND
1 other identifier
observational
1,322
6 countries
27
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
Shorter than P25 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 6, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedSeptember 5, 2017
September 1, 2017
1 year
February 6, 2015
September 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
To describe antibiotic management and document treatment outcome among hospitalized patients with hospital acquired or healthcare associated cUTI, cIAI and NP
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 Outcomes (2)
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
12 months
To describe healthcare utilization and costs associated with hospital acquired or healthcare associated cUTI, cIAI and NP initial antibiotic treatment outcome
12 months
Study Arms (3)
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Research Site
Belo Horizonte, Brazil
Research Site
Campinas, Brazil
Research Site
Porto Alegre, Brazil
Research Site
Argenteuil, France
Research Site
Bordeaux, France
Research Site
Créteil, France
Research Site
Limoges, France
Research Site
Lyon, France
Research Site
Nantes, France
Research Site
Athens, Greece
Research Site
Heraklion, Greece
Research Site
Pátrai, Greece
Research Site
Thessaloniki, Greece
Research Site
Bologna, Italy
Research Site
Brescia, Italy
Research Site
Monza, Italy
Research Site
Roma, Italy
Research Site
Vicenza, Italy
Research Site
Moscow, Russia
Research Site
Novosibirsk, Russia
Research Site
Saint Petersburg, Russia
Research Site
Sestroretsk, Saint Petersburg, Russia
Research Site
Badalona, Spain
Research Site
Barcelona, Spain
Research Site
Oviedo, Spain
Research Site
Seville, Spain
Research Site
Terrassa, Spain
Related Publications (2)
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.
PMID: 29742471DERIVEDKarve 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.
PMID: 29128389DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Laure Fedou
CHU de Limoges - Hôpital Dupuytren
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2015
First Posted
February 18, 2015
Study Start
February 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
September 5, 2017
Record last verified: 2017-09