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Clinical Outcomes in Patients With Infection by Resistant Microorganism

Clinical Outcomes in Patients With Infection by Resistant Microorganism

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05880069
Enrollment
5000
Registered
2023-05-30
Start date
2022-10-01
Completion date
2023-10-31
Last updated
2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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)?

Interventions

OTHERPathogen resistant phenotype

Drug resistant phenotype of the target pathogen under study

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
CollaboratorOTHER
Hospital Universitario Virgen Macarena
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
MortalityThrough study completion, an average of 1 yearDeath any time after infection, during the follow-up time of the original study.

Secondary

MeasureTime frameDescription
Number of participants with clinical cureThrough study completion, an average of 1 yearAbsence of symptoms after completion of an antibiotic treatment course.
Number of participants with microbiological cureThrough study completion, an average of 1 yearNo isolation of the causal microorganisms after completion of an antibiotic treatment course.
Number of participants with ICU admissionThrough study completion, an average of 1 yearNeed for an admission in ICU setting for more than 24 hours after infection onset.
Number of participants with superinfectionThrough study completion, an average of 1 yearOther infections different from the one under assessment.
Number of participants with cognitive impairment / disabilityThrough study completion, an average of 1 yearImpairment 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 recurrence of infectionThrough study completion, an average of 1 yearInfection with the same organism after more than two weeks of the initial infection.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026