Clinical Outcomes in Patients With Infection by Resistant Microorganism

Pneumonia Clinical Trial

Official title:

Clinical Outcomes in Patients With Infection by Resistant Microorganism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05880069
• Other study ID #: PRIMAVERA
• Status: Enrolling by invitation
• Start date: October 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: May 2023
• Source: Hospital Universitario Virgen Macarena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acinetobacter Infections
• Bloodstream Infection
• Communicable Diseases
• Escherichia Coli
• Escherichia coli Infections
• Infections
• Klebsiella Pneumonia
• Pneumonia
• Pseudomonas Aeruginosa
• Sepsis
• Skin Infection
• Staphylococcus Aureus
• Surgical Site Infection
• Surgical Wound Infection
• Urinary Tract Infections

Intervention

Other:
• Pathogen resistant phenotype
Drug resistant phenotype of the target pathogen under study

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death any time after infection, during the follow-up time of the original study.	Through study completion, an average of 1 year
Secondary	Number of participants with ICU admission	Need for an admission in ICU setting for more than 24 hours after infection onset.	Through study completion, an average of 1 year
Secondary	Number of participants with clinical cure	Absence of symptoms after completion of an antibiotic treatment course.	Through study completion, an average of 1 year
Secondary	Number of participants with microbiological cure	No isolation of the causal microorganisms after completion of an antibiotic treatment course.	Through study completion, an average of 1 year
Secondary	Number of participants with recurrence of infection	Infection with the same organism after more than two weeks of the initial infection.	Through study completion, an average of 1 year
Secondary	Number of participants with superinfection	Other infections different from the one under assessment.	Through study completion, an average of 1 year
Secondary	Number of participants with cognitive impairment / disability	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