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

Pfizer

Status: Completed

Conditions: Nosocomial Pneumonia (NP); Urinary Tract Infection (cUTI); Intra-abdominal Infection (cIAI) and

Study type: Observational

Funder types: Industry

Identifiers

NCT02364284

D4280R00005

Details and patient eligibility

About

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

Full 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]).

Enrollment: 1,322 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,322 participants in 3 patient groups

Urinary Tract Infection (cUTI)

Description:

Patients ≥18 years with diagnosis of urinary tract infection.

Intra Abdominal Infection(cIAI)

Description:

Patients ≥ 18 years with diagnosis of Intra Abdominal Infection

Nosocomial Pneumonia (NP)

Description:

Patients ≥ 18 years with diagnosis of Hospital acquired pneumonia