NCT06542965

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

July 31, 2024

Last Update Submit

August 3, 2024

Conditions

Keywords

Proteus mirabilisbacteremiacarbapenem resistanceresistance mechanismsPCR

Outcome Measures

Primary Outcomes (5)

  • Carbapenem Use

    number of patients using carbapenem before P. mirabilis growth in blood cultures

    1 year

  • Intensive Care Units

    number of patients admission in ıntensive care units before P. mirabilis growth in blood cultures

    1 year

  • Mortality

    number of patients who died

    30 days

  • Length of hospital stay

    Length of hospital stay days

    1 year

  • Presence of chronic disease

    number of patients with chronic disease

    1 year

Study Arms (2)

Case (Patients with carbapenem-resistant P. mirabilis)

Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group

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

Other: Non-Interventional Research

Interventions

Non-Interventional Research

Case (Patients with carbapenem-resistant P. mirabilis)Control (Patients with carbapenem- susceptible P. mirabilis)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Inpatients aged 18 years and older
  • P. mirabilis growth in blood cultures

You may not qualify if:

  • Samples taken in emergency departments, outpatient clinics, day treatment units
  • Recurrent growths of the same patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, 35400, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood culture samples

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Çağlar IRMAK

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Specialists in Infectious Diseases

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 7, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

January 1, 2023

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations