Clinical Outcomes in Patients With Infection by Resistant Microorganism

Andalusian Health Service

Status: Invitation-only

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

Treatments: Other: Pathogen resistant phenotype

Study type: Observational

Funder types: Other

Identifiers

NCT05880069

PRIMAVERA

Details and patient eligibility

About

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)?

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 3 patient groups

Drug-resistant pathogen

Description:

Individuals of all ages with the target pathogen, resistance phenotype, and infection site combinations as follows: 1. P. aeruginosa, carbapenems resistant: BSI 2. A. baumannii, carbapenems resistant: BSI 3. E. coli, 3rd generation cephalosporins resistant: BSI and UTI 4. K. pneumoniae, 3rd generation cephalosporins resistant: BSI 5. K. pneumoniae, carbapenems resistant: BSI 6. S. aureus, methicillin resistant: BSI, pneumonia, SSI and SSTI 7. E faecium, vancomycin resistant: BSI 8. Enterobacterales, 3rd generation cephalosporins resistant: BSI

Treatment:

Other: Pathogen resistant phenotype

Drug-susceptible pathogen

Description:

Individuals of all ages with the target pathogen, susceptible phenotype, and infection site combinations as follows: 1. P. aeruginosa, carbapenems susceptible: BSI 2. A. baumannii, carbapenems susceptible: BSI 3. E. coli, 3rd generation cephalosporins susceptible: BSI and UTI 4. K. pneumoniae, 3rd generation cephalosporins susceptible: BSI 5. K. pneumoniae, carbapenems susceptible: BSI 6. S. aureus, methicillin susceptible: BSI, pneumonia, SSI and SSTI 7. E faecium, vancomycin susceptible: BSI 8. Enterobacterales, 3rd generation cephalosporins susceptible: BSI

Treatment:

Other: Pathogen resistant phenotype

No infection

Description:

Individuals of all ages without the infection under study