E Coli InfectionSHRECNCT04574596
Multi-Drug Resistant Organism (MDRO): Study of Highly Resistant Escherichia Coli
An observational study of E Coli Infection, run by Duke University at 13 sites in United States.
Trial summary
This is a prospective, observational, multicenter, case-control study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- E Coli Infection
- How many people
- 300 participants
- Where
- 13 sitesUnited States
- Study dates
- 12 Nov 2020to 1 Jun 2021
- 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: * Sample size: 300 total: 150 3GCR-Ec cases, 150 3GCS-Ec controls. * This is a consecutive cohort study without age or gender exclusions. Special populations such as women, children, and minorities will be included. * The study population will be drawn from subjects who are hospitalized at participating study hospitals. * This observational study is minimal-risk and will be performed under a waiver of consent and HIPAA.
Who may be able to join
- Positive monomicrobial blood culture for 3GCR-Ec (cases) or 3GCS-Ec (control)
- Hospitalized at the time of obtaining index blood culture OR in the emergency department at the time of obtaining index blood culture, if followed by hospitalization within 72 hours
Who cannot join
- Previously included in this study as either control or case subject
- Previous blood culture positive for E. coli during the current hospitalization
- In vitro non-susceptibility to any carbapenem tested in the local clinical microbiology laboratory
- Evidence of carbapenemase production in the E. coli isolate of interest as determined by the local clinical microbiology laboratory
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Case Western Reserve University
Cleveland, Ohio, 44106-7282
Henry Ford Health System
Detroit, Michigan, 48202
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Ochsner Medical Center
New Orleans, Louisiana, 21287
Weill Cornell Medical College
New York, New York, 10021
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Mayo Clinic
Rochester, Minnesota, 55905
Harbor-University of California Los Angeles Medical Center
Torrance, California, 90502
About this study
Official title: MDRO: Study of Highly Resistant Escherichia Coli
This is a prospective, observational, multicenter, case-control study.
Read the detailed description
This is an observational cohort study. A total of 300 subjects will be enrolled. Cases are defined as unique subjects who have a monomicrobial blood culture positive for growth of 3rd Generation Cephalosporin Resistant Escherichia coli (3GCR-Ec), defined as resistance to ceftriaxone or cefotaxime, during hospitalization. For each case, the next available unique subject from the same study site, with a monomicrobial blood culture positive for growth of 3rd Generation Cephalosporin Sensitive Escherichia coli (3GCS-Ec) during hospitalization will be included as a control. A waiver of informed consent and HIPAA will be requested. This is a minimal risk study without any direct subject contact. In addition, no subject information will be collected that is not part of routine clinical care.
The trigger for enrollment in the study will be the identification in a participating local microbiology laboratory of a 3GCR-Ec in a monomicrobial blood culture. These will be reported to study personnel at the study site, who will evaluate eligibility. If the subject is deemed eligible, the 3GCR-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate also saved at the local laboratory. Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study. The local microbiology laboratory, or designee, will then identify the next subject available with a 3GCS-Ec in a blood culture. These will also be reported to study personnel for evaluation of eligibility as a control. If the control subject is eligible, the corresponding 3GCS-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate will also be saved at the local laboratory . Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study.
For cases and controls, clinical data will be collected from the electronic health records (EHR) for up to 30 days after the index blood culture. Data collection will be performed by study personnel at the site into a central, secure, research database.
One E. coli isolate per study subject will be collected from the index blood culture. No other biologic samples will be collected. Data will be entered at or after the 30-day time point. There will be no long-term follow-up for subjects.
Primary Objective:
To evaluate the use of oral step down therapy in subjects with 3GCR-Ec and 3GCS-Ec bacteremia.
Secondary Objectives
- To describe the treatment regimens used in subjects with 3GCR-Ec and 3GCS-Ec bacteremia.
- To determine the association between duration of intravenous antibiotics and Inverse Probability Weighting (IPW)-adjusted Desirability Of Outcome Ranking (DOOR) outcomes at 30 days
- To determine the association between total duration of antibiotics and IPW-adjusted DOOR outcomes at 30 days
- To determine risk factors on days 0, 3, 5, and 7 after first positive blood culture for poor outcomes (either DOOR composite score or individual outcomes) at 30 days.
Exploratory Objective:
- To describe phenotypic and genotypic characteristics of bacterial isolates.
This study is minimal risk to study participants, and has no data safety monitoring board.
- Conditions
- E Coli Infection
- Being tested
- no Intervention
- Keywords
- Extended Spectrum β-Lactamases (ESBL)
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no InterventionOther
This is an observational study. There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| 3GCR ceftriaxone-resistant-E. coli | Positive blood culture for above resistant e coli. Observational there will be no intervention Receives: Other: no Intervention | |
| 3GCS ceftriaxone-susceptible-E. coli | Positive blood culture for above susceptible e coli. Observational there will be no intervention Receives: Other: no Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who received oral step-down therapy
Number of participants who received oral-step down therapy for treatment of e. Coli
Measured: Within 30 days of culture collection
Secondary outcomes (18)
Duration of antibiotics
Total duration of antibiotics
Measured: From culture collection to 30 days post culture collection
Duration of intravenous antibiotics
Total duration of intravenous antibiotics
Measured: From culture collection to 30 days post culture collection
Duration of oral antibiotics
Total duration of oral antibiotics
Measured: From culture collection to 30 days post culture collection
Number of participants who received short course antibiotic therapy
Number of participants who received short-course antibiotic therapy defined as <= 7 days of antibiotic therapy
Measured: From culture collection to 30 days post culture collection
Number of participants with ongoing antibiotic treatment at 30 days
Number of participants with ongoing antibiotic treatment at 30 days
Measured: 30 days post culture collection
Number of participants with resolution or improvement of symptoms
Number of participants with resolution or improvement of symptoms by 30 days
Measured: 30 days post culture collection
Number of participants with anatomic source specific symptomatic response
Number of participants with anatomic source specific symptomatic response
Measured: 30 days post culture collection
Discharged by 30 days
Discharged from the hospital by 30 days
Measured: culture collection through 30 days post culture collection
Days to discharge
Days from culture collection to hospital discharge
Measured: culture collection through 30 days post culture collection
Length of stay
Days from hospital admission to hospital discharge
Measured: hospital admission through 30 days post culture collection
Number of participants with a readmission within 30 days of index culture
Number of participants with a readmission to the same hospital within 30 days of index culture
Measured: culture collection through 30 days post culture collection
Number of participants with a new positive blood culture with E. coli within 30 days of index culture
Number of participants with a new positive blood culture with E. coli within 30 days of index culture
Measured: culture collection through 30 days post culture collection
Number of participants with a three-fold or greater increase in serum creatinine from day of index culture
Number of participants with a three-fold or greater increase in serum creatinine from day of index culture
Measured: culture collection through 30 days post culture collection
Number of participants with a newly required renal replacement therapy post index culture
Number of participants with a newly required renal replacement therapy post index culture
Measured: culture collection through 30 days post culture collection
Number of participants with a Clostridioides difficile infection
Number of participants with a Clostridioides difficile infection
Measured: culture collection through 30 days post culture collection
Mortality at 30 days
Mortality at 30 days
Measured: culture collection through 30 days post culture collection
Number of participants in the ICU on day 0, 3, 5, and 7
Number of participants in the ICU on day 0, 3, 5, and 7
Measured: Days 0, 3, 5, 7
Desireability of Outcome Ranking (DOOR) outcome at 30 days
The desirability of outcome ranking (DOOR) in this study will assess three deleterious events (lack of clinical response, unsuccessful discharge, and undesirable events) in addition to survival at 30 days after the index culture. The five ordered levels of the variable, from best to worst, are:
- Alive without deleterious events
- Alive with 1 deleterious event
- Alive with 2 deleterious events
- Alive with 3 deleterious events
- Death by 30 days
The undesirable events are:
- Post-culture renal failure
- Clostridioides difficile infection
Measured: 30 days post culture collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start12 Nov 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E Coli InfectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vance G. Fowler, MD, Study director, Duke Clinical Research InstituteDavid van Duin, MD, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574596
- Sponsor's protocol ID
- Pro00106280
- Other IDs
- UM1AI104681
- Acronym
- SHREC
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 27 Jul 2021
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDRO: Study of Highly Resistant Escherichia Coli
- ClinicalTrials.gov ID
- NCT04574596
- Acronym / sponsor ID
- SHREC / Pro00106280
- Conditions
- E Coli Infection
- Keywords
- Extended Spectrum β-Lactamases (ESBL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Oct 2020 (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 is a prospective, observational, multicenter, case-control study.
Detailed description
This is an observational cohort study. A total of 300 subjects will be enrolled. Cases are defined as unique subjects who have a monomicrobial blood culture positive for growth of 3rd Generation Cephalosporin Resistant Escherichia coli (3GCR-Ec), defined as resistance to ceftriaxone or cefotaxime, during hospitalization. For each case, the next available unique subject from the same study site, with a monomicrobial blood culture positive for growth of 3rd Generation Cephalosporin Sensitive Escherichia coli (3GCS-Ec) during hospitalization will be included as a control. A waiver of informed consent and HIPAA will be requested. This is a minimal risk study without any direct subject contact. In addition, no subject information will be collected that is not part of routine clinical care.
The trigger for enrollment in the study will be the identification in a participating local microbiology laboratory of a 3GCR-Ec in a monomicrobial blood culture. These will be reported to study personnel at the study site, who will evaluate eligibility. If the subject is deemed eligible, the 3GCR-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate also saved at the local laboratory. Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study. The local microbiology laboratory, or designee, will then identify the next subject available with a 3GCS-Ec in a blood culture. These will also be reported to study personnel for evaluation of eligibility as a control. If the control subject is eligible, the corresponding 3GCS-Ec isolate will be saved for shipping to the Laboratory Center, and the isolate will also be saved at the local laboratory . Sites will be advised to destroy any samples saved at the local laboratory as part of this study at the end of the study.
For cases and controls, clinical data will be collected from the electronic health records (EHR) for up to 30 days after the index blood culture. Data collection will be performed by study personnel at the site into a central, secure, research database.
One E. coli isolate per study subject will be collected from the index blood culture. No other biologic samples will be collected. Data will be entered at or after the 30-day time point. There will be no long-term follow-up for subjects.
Primary Objective:
To evaluate the use of oral step down therapy in subjects with 3GCR-Ec and 3GCS-Ec bacteremia.
Secondary Objectives
- To describe the treatment regimens used in subjects with 3GCR-Ec and 3GCS-Ec bacteremia.
- To determine the association between duration of intravenous antibiotics and Inverse Probability Weighting (IPW)-adjusted Desirability Of Outcome Ranking (DOOR) outcomes at 30 days
- To determine the association between total duration of antibiotics and IPW-adjusted DOOR outcomes at 30 days
- To determine risk factors on days 0, 3, 5, and 7 after first positive blood culture for poor outcomes (either DOOR composite score or individual outcomes) at 30 days.
Exploratory Objective:
- To describe phenotypic and genotypic characteristics of bacterial isolates.
This study is minimal risk to study participants, and has no data safety monitoring board.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3GCR ceftriaxone-resistant-E. coli | – | Other: no InterventionPositive blood culture for above resistant e coli. Observational there will be no intervention |
| 3GCS ceftriaxone-susceptible-E. coli | – | Other: no InterventionPositive blood culture for above susceptible e coli. Observational there will be no intervention |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * Sample size: 300 total: 150 3GCR-Ec cases, 150 3GCS-Ec controls. * This is a consecutive cohort study without age or gender exclusions. Special populations such as women, children, and minorities will be included. * The study population will be drawn from subjects who are hospitalized at participating study hospitals. * This observational study is minimal-risk and will be performed under a waiver of consent and HIPAA.
Key inclusion criteria (2 listed)
- Positive monomicrobial blood culture for 3GCR-Ec (cases) or 3GCS-Ec (control)
- Hospitalized at the time of obtaining index blood culture OR in the emergency department at the time of obtaining index blood culture, if followed by hospitalization within 72 hours
Key exclusion criteria (4 listed)
- Previously included in this study as either control or case subject
- Previous blood culture positive for E. coli during the current hospitalization
- In vitro non-susceptibility to any carbapenem tested in the local clinical microbiology laboratory
- Evidence of carbapenemase production in the E. coli isolate of interest as determined by the local clinical microbiology laboratory
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 |
|---|---|---|
| no InterventionThis is an observational study. There is no intervention | Other | 3GCR ceftriaxone-resistant-E. coli, 3GCS ceftriaxone-susceptible-E. coli |
Primary outcome
Number of participants who received oral step-down therapy
Time frame: Within 30 days of culture collection
Number of participants who received oral-step down therapy for treatment of e. Coli
18 secondary outcomes
Duration of antibiotics
Time frame: From culture collection to 30 days post culture collection
Duration of intravenous antibiotics
Time frame: From culture collection to 30 days post culture collection
Duration of oral antibiotics
Time frame: From culture collection to 30 days post culture collection
Number of participants who received short course antibiotic therapy
Time frame: From culture collection to 30 days post culture collection
Number of participants with ongoing antibiotic treatment at 30 days
Time frame: 30 days post culture collection
Number of participants with resolution or improvement of symptoms
Time frame: 30 days post culture collection
Number of participants with anatomic source specific symptomatic response
Time frame: 30 days post culture collection
Discharged by 30 days
Time frame: culture collection through 30 days post culture collection
Days to discharge
Time frame: culture collection through 30 days post culture collection
Length of stay
Time frame: hospital admission through 30 days post culture collection
Number of participants with a readmission within 30 days of index culture
Time frame: culture collection through 30 days post culture collection
Number of participants with a new positive blood culture with E. coli within 30 days of index culture
Time frame: culture collection through 30 days post culture collection
Number of participants with a three-fold or greater increase in serum creatinine from day of index culture
Time frame: culture collection through 30 days post culture collection
Number of participants with a newly required renal replacement therapy post index culture
Time frame: culture collection through 30 days post culture collection
Number of participants with a Clostridioides difficile infection
Time frame: culture collection through 30 days post culture collection
Mortality at 30 days
Time frame: culture collection through 30 days post culture collection
Number of participants in the ICU on day 0, 3, 5, and 7
Time frame: Days 0, 3, 5, 7
Desireability of Outcome Ranking (DOOR) outcome at 30 days
Time frame: 30 days post culture collection
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 27 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Vance G. Fowler, MD study director
Duke Clinical Research Institute
David van Duin, MD, PhD principal investigator
University of North Carolina
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of E Coli Infection, run by Duke University at 13 sites in United States.
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 4 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
Number of participants who received oral step-down therapy (time frame: Within 30 days of culture collection). 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 27 Jul 2021.