Clinical Outcomes in Patients With Infection by Resistant Microorganism

• Conditions: Skin Infection; Enterococcus Faecium Infection; Pseudomonas Aeruginosa; Surgical Site Infection; Klebsiella Pneumonia; Pneumonia; Bloodstream Infection; Escherichia Coli; Staphylococcus Aureus; Urinary Tract Infections

• Registration Number: NCT05880069
• Lead Sponsor: Hospital Universitario Virgen Macarena

Brief Summary

The goal of this individual patient data meta-analysis is to estimate the attributed and the associated health burden related to bloodstream infections, pneumonia, skin and soft tissue infections, surgical site infections and urinary tract infections, caused by target drug-resistant pathogens, in high income countries.

The main question\[s\] it aims to answer are:

* Are common infections caused by drug-resistant pathogens associated with an increased health burden, when compared with individuals with the same infection caused by a susceptible strain (attributed burden)?

* Are common infections caused by drug-resistant pathogens associated with an increase health burden, when compared with individuals without the infection under study (associated burden)?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-18
• Last Update Submitted: 2023-05-18
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30
• Primary Completion: 2023-06
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Individuals of all ages
• Individuals with hospital acquired, community acquired, or healthcare associated infections
• Individuals treated at hospital level, community, or long-term care facilities
• Individuals with the targeted pathogen, resistance phenotype, and infection site combinations under study

Exclusion Criteria

• Individuals with infections in the following systems: central nervous system, genital system, pelvic infections and head and neck infections
• Individuals with the following specific primary infections: endocarditis, upper respiratory tract infections, lung abscess
• Individuals with bacterial infections not included in the table of pathogens of interest, polymicrobial infections except for intraabdominal infections, fungal infections, parasitic infections, viral infections, mycobacterial infections, sexually transmitted diseases, and zoonotic infections

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Through study completion, an average of 1 year	Death any time after infection, during the follow-up time of the original study.

Secondary Outcome Measures

Name	Time	Method
Number of participants with ICU admission	Through study completion, an average of 1 year	Need for an admission in ICU setting for more than 24 hours after infection onset.
Number of participants with recurrence of infection	Through study completion, an average of 1 year	Infection with the same organism after more than two weeks of the initial infection.
Number of participants with cognitive impairment / disability	Through study completion, an average of 1 year	Impairment is any temporal or permanent loss of function; disability is a restriction or inability to perform a normal activity resulting from an impairment. Assessed using Center for Epidemiologic Studies Depression Scale (CES-D), Mini-Mental State Examination (MMSE) or Trail Making Test (TMT).
Number of participants with superinfection	Through study completion, an average of 1 year	Other infections different from the one under assessment.
Number of participants with clinical cure	Through study completion, an average of 1 year	Absence of symptoms after completion of an antibiotic treatment course.
Number of participants with microbiological cure	Through study completion, an average of 1 year	No isolation of the causal microorganisms after completion of an antibiotic treatment course.

Trial Locations

Locations (1)

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain