Gram-Negative Bacterial InfectionsNCT04055922
Comparison of Solid Organ Transplant
An observational study of Gram-Negative Bacterial Infections and Gram-negative Bacteremia, run by Methodist Health System at 1 site in United States.
Trial summary
Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-Negative Bacterial Infections, Gram-negative Bacteremia, Multidrug-Resistant Organism
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Solid organ transplant (SOT) recipients
Who may be able to join
- 18 years or older
Who cannot join
- Missing data necessary to determine study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Comparison of Solid Organ Transplant Specific and Hospital-wide Gram-Negative Antibiograms
Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients.
Read the detailed description
There is limited guidance for empiric antimicrobial therapy in this population. Local epidemiology plays a voluble role in managing infections empirically within the hospital setting. Antibiograms can serve as a critical tool in optimizing empiric antimicrobial decisions. Refining antibiogram data to specific populations such as SOT patients may allow for timelier and appropriate empiric use of antimicrobials, and improve clinical outcomes.
Time to appropriate therapy (antimicrobial testing susceptible in vitro to the pathogen identified) is of vital importance in management of serious infections. SOT may have different resistance rates at Methodist Dallas Medical Center making the applicability of the yearly hospital-wide antibiogram unknown for use in this specialized patient population. A SOT-Specific antibiogram may highlight common resistance patterns identified in pathogens seen in this patient population. Additionally, this investigation may further emphasize the importance of antimicrobial stewardship activities such as: appropriate empiric antibacterial decisions, de-escalation, and effective durations of therapy.
- Conditions
- Gram-Negative Bacterial Infections, Gram-negative Bacteremia, Multidrug-Resistant Organism, Hospital-acquired Pneumonia, Healthcare-associated Pneumonia
- Medical subject headings
- Gram-Negative Bacterial Infections, Healthcare-Associated Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a liver transplant specific antibiogram
Creation of a liver transplant specific antibiogram (cumulative susceptibility rates per bacterial organism for select antibiotics)
Measured: Jan 1, 2012 - December 31, 2016
Creation of a kidney transplant specific antibiogram
Creation of a kidney transplant specific antibiogram (cumulative susceptibility rates per bacterial organism for select antibiotics)
Measured: Jan 1, 2012 - December 31, 2016
Comparison of SOT
Comparison of SOT (liver and kidney) antibiograms with the hospital-wide antibiogram
Measured: Jan 1, 2012 - December 31, 2016
Secondary outcomes (2)
Creation of transplant antibiogram for subgroups
Creation of transplant antibiogram for subgroups of patients including the following: ICU patients, Kidney transplant urinary tract infections (UTI), SOT bloodstream infections (BSI)
Measured: Jan 1, 2012 - December 31, 2016
Identification of risk factors among liver transplant recipients
Identification of risk factors among liver transplant recipients for vancomycin-resistant enterococci infections
Measured: Jan 1, 2012 - December 31, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start3 May 2018
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Negative Bacterial InfectionsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matt Crotty, PharmD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055922
- Sponsor's protocol ID
- 058.PHA.2017.D
- Status last verified
- Apr 2019
- First submitted
- 12 Aug 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Solid Organ Transplant Specific and Hospital-wide Gram-Negative Antibiograms
- ClinicalTrials.gov ID
- NCT04055922
- Acronym / sponsor ID
- 058.PHA.2017.D
- Conditions
- Gram-Negative Bacterial Infections, Gram-negative Bacteremia, Multidrug-Resistant Organism, Hospital-acquired Pneumonia, Healthcare-associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 14 Aug 2019 (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.
Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients.
Detailed description
There is limited guidance for empiric antimicrobial therapy in this population. Local epidemiology plays a voluble role in managing infections empirically within the hospital setting. Antibiograms can serve as a critical tool in optimizing empiric antimicrobial decisions. Refining antibiogram data to specific populations such as SOT patients may allow for timelier and appropriate empiric use of antimicrobials, and improve clinical outcomes.
Time to appropriate therapy (antimicrobial testing susceptible in vitro to the pathogen identified) is of vital importance in management of serious infections. SOT may have different resistance rates at Methodist Dallas Medical Center making the applicability of the yearly hospital-wide antibiogram unknown for use in this specialized patient population. A SOT-Specific antibiogram may highlight common resistance patterns identified in pathogens seen in this patient population. Additionally, this investigation may further emphasize the importance of antimicrobial stewardship activities such as: appropriate empiric antibacterial decisions, de-escalation, and effective durations of therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Solid organ transplant (SOT) recipients
Key inclusion criteria (1 listed)
- 18 years or older
Key exclusion criteria (1 listed)
- Missing data necessary to determine study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a liver transplant specific antibiogram
Time frame: Jan 1, 2012 - December 31, 2016
Creation of a liver transplant specific antibiogram (cumulative susceptibility rates per bacterial organism for select antibiotics)
Creation of a kidney transplant specific antibiogram
Time frame: Jan 1, 2012 - December 31, 2016
Creation of a kidney transplant specific antibiogram (cumulative susceptibility rates per bacterial organism for select antibiotics)
Comparison of SOT
Time frame: Jan 1, 2012 - December 31, 2016
Comparison of SOT (liver and kidney) antibiograms with the hospital-wide antibiogram
2 secondary outcomes
Creation of transplant antibiogram for subgroups
Time frame: Jan 1, 2012 - December 31, 2016
Identification of risk factors among liver transplant recipients
Time frame: Jan 1, 2012 - December 31, 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- 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.
Matt Crotty, PharmD principal investigator
Methodist Health System
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 Gram-Negative Bacterial Infections and Gram-negative Bacteremia, run by Methodist Health System at 1 site 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 1 inclusion and 1 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 2 Jan 2020. 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 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?
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?
Creation of a liver transplant specific antibiogram (time frame: Jan 1, 2012 - December 31, 2016). The study lists 3 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 2 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.