Clinical Outcomes in Patients With Infection by Resistant Microorganism

NCT05880069 | Unknown

• 1 other identifier: PRIMAVERA
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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)?

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death any time after infection, during the follow-up time of the original study.

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Number of participants with ICU admission

  Through study completion, an average of 1 year

• Number of participants with clinical cure

  Through study completion, an average of 1 year

• Number of participants with microbiological cure

  Through study completion, an average of 1 year

• Number of participants with recurrence of infection

  Through study completion, an average of 1 year

• Number of participants with superinfection

  Through study completion, an average of 1 year

Study Arms (3)

Drug-resistant pathogen

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

Other: Pathogen resistant phenotype

Drug-susceptible pathogen

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

Other: Pathogen resistant phenotype

No infection

Individuals of all ages without the infection under study

Interventions

Pathogen resistant phenotype OTHER

Drug resistant phenotype of the target pathogen under study

Drug-resistant pathogen; Drug-susceptible pathogen

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: collaborator

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

Pneumonia; Sepsis; Urinary Tract Infections; Cellulitis; Surgical Wound Infection; Staphylococcal Infections; Escherichia coli Infections; Acinetobacter Infections; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Wound Infection; Postoperative Complications; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Moraxellaceae Infections

Study Officials

• Jesús Rodríguez-Baño, MD PhD

  Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 30, 2023
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

ES (1)