PneumoniaNCT05880069
Clinical Outcomes in Patients With Infection by Resistant Microorganism
An observational study of Pneumonia and Bloodstream Infection, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia, Bloodstream Infection, Urinary Tract Infections
- What is being tested?
- Pathogen resistant phenotype
- How many people
- 5,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Pathogen resistant phenotype
- Medical subject headings
- Pneumonia, Sepsis, Urinary Tract Infections, Cellulitis, Surgical Wound Infection, Staphylococcal Infections, Escherichia coli Infections, Acinetobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathogen resistant phenotypeOther
Drug resistant phenotype of the target pathogen under study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Pathogen resistant phenotype | |
| No infection | Individuals of all ages without the infection under study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death any time after infection, during the follow-up time of the original study.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Number of participants with ICU admission
Need for an admission in ICU setting for more than 24 hours after infection onset.
Measured: Through study completion, an average of 1 year
Number of participants with clinical cure
Absence of symptoms after completion of an antibiotic treatment course.
Measured: Through study completion, an average of 1 year
Number of participants with microbiological cure
No isolation of the causal microorganisms after completion of an antibiotic treatment course.
Measured: Through study completion, an average of 1 year
Number of participants with recurrence of infection
Infection with the same organism after more than two weeks of the initial infection.
Measured: Through study completion, an average of 1 year
Number of participants with superinfection
Other infections different from the one under assessment.
Measured: Through study completion, an average of 1 year
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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Oct 2022
- Primary completionJun 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Responsible party
- Sponsor
- Investigators
- Jesús Rodríguez-Baño, MD PhD, Study director, Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880069
- Sponsor's protocol ID
- PRIMAVERA
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Patients With Infection by Resistant Microorganism
- ClinicalTrials.gov ID
- NCT05880069
- Acronym / sponsor ID
- PRIMAVERA
- Conditions
- Pneumonia, Bloodstream Infection, Urinary Tract Infections, Skin Infection, Surgical Site Infection, Staphylococcus Aureus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug-resistant pathogen | – | Other: Pathogen resistant phenotypeIndividuals 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 |
| Drug-susceptible pathogen | – | Other: Pathogen resistant phenotypeIndividuals 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 |
| No infection | – | –Individuals of all ages without the infection under study |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathogen resistant phenotypeDrug resistant phenotype of the target pathogen under study | Other | Drug-resistant pathogen, Drug-susceptible pathogen |
Primary outcome
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.
6 secondary outcomes
Number of participants with ICU admission
Time frame: Through study completion, an average of 1 year
Number of participants with clinical cure
Time frame: Through study completion, an average of 1 year
Number of participants with microbiological cure
Time frame: 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
Number of participants with superinfection
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús Rodríguez-Baño, MD PhD study director
Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Bloodstream Infection, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.