Clinical Outcomes in Patients With Infection by Resistant Microorganism

May 18, 2023 updated by: Hospital Universitario Virgen Macarena

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)?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain
        • Hospital Universitario Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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
Other: Pathogen resistant phenotype
Drug resistant phenotype of the target pathogen under study
No infection
Individuals of all ages without the infection under study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Through study completion, an average of 1 year
Death any time after infection, during the follow-up time of the original study.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with ICU admission
Time Frame: Through study completion, an average of 1 year
Need for an admission in ICU setting for more than 24 hours after infection onset.
Through study completion, an average of 1 year
Number of participants with clinical cure
Time Frame: Through study completion, an average of 1 year
Absence of symptoms after completion of an antibiotic treatment course.
Through study completion, an average of 1 year
Number of participants with microbiological cure
Time Frame: Through study completion, an average of 1 year
No isolation of the causal microorganisms after completion of an antibiotic treatment course.
Through study completion, an average of 1 year
Number of participants with recurrence of infection
Time Frame: Through study completion, an average of 1 year
Infection with the same organism after more than two weeks of the initial infection.
Through study completion, an average of 1 year
Number of participants with superinfection
Time Frame: Through study completion, an average of 1 year
Other infections different from the one under assessment.
Through study completion, an average of 1 year
Number of participants with cognitive impairment / disability
Time Frame: Through study completion, an average of 1 year
Impairment 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).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen Macarena

Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Study Director: Jesús Rodríguez-Baño, MD PhD, Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIMAVERA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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