Clinical trial NCT05880069: Clinical Outcomes in Patients With Infection by Resistant Microorganism
Official title: Clinical Outcomes in Patients With Infection by Resistant Microorganism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia
Bloodstream Infection
Urinary Tract Infections
Skin Infection
Surgical Site Infection
Staphylococcus Aureus
Klebsiella Pneumonia
Escherichia Coli
Enterococcus Faecium Infection
Acinetobacter Infections
Pseudomonas Aeruginosa
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
First posted: 2023-05-30
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Individuals of all ages with the target pathogen, resistance phenotype, and infection site combinations as follows:

   * P. aeruginosa, carbapenems resistant: BSI
   * A. baumannii, carbapenems resistant: BSI
   * E. coli, 3rd generation cephalosporins resistant: BSI and UTI
   * K. pneumoniae, 3rd generation cephalosporins resistant: BSI
   * K. pneumoniae, carbapenems resistant: BSI
   * S. aureus, methicillin resistant: BSI, pneumonia, SSI and SSTI
   * E faecium, vancomycin resistant: BSI
   * Enterobacterales, 3rd generation cephalosporins resistant: BSI
2. Individuals of all ages with the same infection caused by the target drug-susceptible pathogen
3. Individuals of all ages without the infection under study

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)?


Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants with ICU admission
timeFrame: Through study completion, an average of 1 year
measure: Number of participants with clinical cure
timeFrame: Through study completion, an average of 1 year
measure: Number of participants with microbiological cure
timeFrame: Through study completion, an average of 1 year
measure: Number of participants with recurrence of infection
timeFrame: Through study completion, an average of 1 year
measure: Number of participants with superinfection
timeFrame: Through study completion, an average of 1 year
measure: Number of participants with cognitive impairment / disability
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
name: Jesús Rodríguez-Baño, MD PhD
role: STUDY_DIRECTOR
References: