Proteus Mirabilis InfectionNCT06542965
Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis
An observational study of Proteus Mirabilis Infection and Bacteremia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the clinical characteristics, risk factors, and resistance mechanisms of patients with carbapenem-resistant P. mirabilis bacteremia.Patients with P. mirabilis growth in blood culture samples sent to bacteriology laboratory between 2018 and 2021 were retrospectively analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proteus Mirabilis Infection, Bacteremia, Carbapenem Resistant Bacterial Infection
- What is being tested?
- Non-Interventional Research
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2023
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: . Inpatients aged 18 years and older with P. mirabilis growth in blood cultures were included in the study, while samples taken in emergency departments, outpatient clinics, day treatment units and recurrent growths of the same patient were excluded.
Who may be able to join
- Inpatients aged 18 years and older
- P. mirabilis growth in blood cultures
Who cannot join
- Samples taken in emergency departments, outpatient clinics, day treatment units
- Recurrent growths of the same patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characteristics, Risk Factors and Resistance Mechanisms for Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis
This study aims to determine the clinical characteristics, risk factors, and resistance mechanisms of patients with carbapenem-resistant P. mirabilis bacteremia.Patients with P. mirabilis growth in blood culture samples sent to bacteriology laboratory between 2018 and 2021 were retrospectively analyzed. Patients meeting the inclusion criteria were divided into carbapenem-resistant and carbapenem- susceptible groups. The investigators recorded demographic data, clinical features, and laboratory findings. Resistance genes were investigated in carbapenem-resistant isolates using PCR.
Read the detailed description
Patients with P. mirabilis growth in blood culture who met the study criteria were divided into two groups as carbapenem susceptible and resistant according to carbapenem antibiogram results. Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group and patients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group.
Demographic characteristics of the patients, concomitant chronic diseases, Charlson comorbidity index (CCI), hospital and intensive care unit (ICU) hospitalization and number of days in the last year, history and type of invasive intervention in the last three months (surgical-invasive), history of antibiotic use in the last three months and types of antibiotics used (Penicillin, cephalosporin, quinolone, carbapenem, tigecycline, colistin, aminoglycoside), hospitalization unit, total length of hospitalization, sample collection unit, growth result and antibiogram, clinical and laboratory data of the day of growth, sepsis and septic shock evaluated according to systemic inflammatory response syndrome (SIRS) criteria, 30-day mortality and patient outcome information were recorded.
Carbapenemase-producing gene regions were investigated by Polymerase Chain Reaction (PCR) in accessible samples of patients with carbapenem-resistant P. mirabilis growth in blood cultures.
- Being tested
- Non-Interventional Research
- Keywords
- Proteus mirabilis, bacteremia, carbapenem resistance, resistance mechanisms, PCR
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional ResearchOther
Non-Interventional Research
| Study group | Role | What they receive |
|---|---|---|
| Case (Patients with carbapenem-resistant P. mirabilis) | Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group Receives: Other: Non-Interventional Research | |
| Control (Patients with carbapenem- susceptible P. mirabilis) | Patients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group Receives: Other: Non-Interventional Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbapenem Use
number of patients using carbapenem before P. mirabilis growth in blood cultures
Measured: 1 year
Intensive Care Units
number of patients admission in ıntensive care units before P. mirabilis growth in blood cultures
Measured: 1 year
Mortality
number of patients who died
Measured: 30 days
Length of hospital stay
Length of hospital stay days
Measured: 1 year
Presence of chronic disease
number of patients with chronic disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proteus Mirabilis InfectionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cağlar Iirmak, Dokuz Eylul University
- Investigators
- Çağlar IRMAK, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542965
- Sponsor's protocol ID
- DEU-INF-IRMAK-1
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Risk Factors and Resistance Mechanisms for Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis
- ClinicalTrials.gov ID
- NCT06542965
- Acronym / sponsor ID
- DEU-INF-IRMAK-1
- Keywords
- Proteus mirabilis, bacteremia, carbapenem resistance, resistance mechanisms, PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 7 Aug 2024 (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.
This study aims to determine the clinical characteristics, risk factors, and resistance mechanisms of patients with carbapenem-resistant P. mirabilis bacteremia.Patients with P. mirabilis growth in blood culture samples sent to bacteriology laboratory between 2018 and 2021 were retrospectively analyzed. Patients meeting the inclusion criteria were divided into carbapenem-resistant and carbapenem- susceptible groups. The investigators recorded demographic data, clinical features, and laboratory findings. Resistance genes were investigated in carbapenem-resistant isolates using PCR.
Detailed description
Patients with P. mirabilis growth in blood culture who met the study criteria were divided into two groups as carbapenem susceptible and resistant according to carbapenem antibiogram results. Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group and patients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group.
Demographic characteristics of the patients, concomitant chronic diseases, Charlson comorbidity index (CCI), hospital and intensive care unit (ICU) hospitalization and number of days in the last year, history and type of invasive intervention in the last three months (surgical-invasive), history of antibiotic use in the last three months and types of antibiotics used (Penicillin, cephalosporin, quinolone, carbapenem, tigecycline, colistin, aminoglycoside), hospitalization unit, total length of hospitalization, sample collection unit, growth result and antibiogram, clinical and laboratory data of the day of growth, sepsis and septic shock evaluated according to systemic inflammatory response syndrome (SIRS) criteria, 30-day mortality and patient outcome information were recorded.
Carbapenemase-producing gene regions were investigated by Polymerase Chain Reaction (PCR) in accessible samples of patients with carbapenem-resistant P. mirabilis growth in blood cultures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (Patients with carbapenem-resistant P. mirabilis) | – | Other: Non-Interventional ResearchPatients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group |
| Control (Patients with carbapenem- susceptible P. mirabilis) | – | Other: Non-Interventional ResearchPatients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- . Inpatients aged 18 years and older with P. mirabilis growth in blood cultures were included in the study, while samples taken in emergency departments, outpatient clinics, day treatment units and recurrent growths of the same patient were excluded.
Key inclusion criteria (2 listed)
- Inpatients aged 18 years and older
- P. mirabilis growth in blood cultures
Key exclusion criteria (2 listed)
- Samples taken in emergency departments, outpatient clinics, day treatment units
- Recurrent growths of the same patient
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 |
|---|---|---|
| Non-Interventional ResearchNon-Interventional Research | Other | Case (Patients with carbapenem-resistant P. mirabilis), Control (Patients with carbapenem- susceptible P. mirabilis) |
Primary outcome
Carbapenem Use
Time frame: 1 year
number of patients using carbapenem before P. mirabilis growth in blood cultures
Intensive Care Units
Time frame: 1 year
number of patients admission in ıntensive care units before P. mirabilis growth in blood cultures
Mortality
Time frame: 30 days
number of patients who died
Length of hospital stay
Time frame: 1 year
Length of hospital stay days
Presence of chronic disease
Time frame: 1 year
number of patients with chronic disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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.
Çağlar IRMAK principal investigator
Dokuz Eylul University
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 Proteus Mirabilis Infection and Bacteremia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Aug 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Carbapenem Use (time frame: 1 year). The study lists 5 primary outcomes in all. 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 7 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.