Clinical Outcomes in Patients With Infection by Resistant Microorganism
NCT ID: NCT05880069
Last Updated: 2023-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2022-10-01
2023-10-31
Brief Summary
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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)?
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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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
Pathogen resistant phenotype
Drug resistant phenotype of the target pathogen under study
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
Pathogen resistant phenotype
Drug resistant phenotype of the target pathogen under study
No infection
Individuals of all ages without the infection under study
No interventions assigned to this group
Interventions
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Pathogen resistant phenotype
Drug resistant phenotype of the target pathogen under study
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Hospital Universitario Virgen Macarena
OTHER
Responsible Party
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Principal Investigators
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Jesús Rodríguez-Baño, MD PhD
Role: STUDY_DIRECTOR
Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
Locations
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Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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Other Identifiers
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PRIMAVERA
Identifier Type: -
Identifier Source: org_study_id
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