Urinary Tract Infection, ComplicatedNCT02420366
Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
An observational study of Urinary Tract Infection, Complicated and Acute Pyelonephritis, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) at 22 sites in 4 countries.
Trial summary
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection, Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia
- How many people
- 257 participants
- Where
- 22 sitesin 4 countries
- Study dates
- May 2014to Jan 2015
- 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: Subjects with serious CRE infections identified by chart review at up to 20 sites
Who may be able to join
- Male or female ≥18 years of age.
- Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP, VABP, and/or bacteremia.
- Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia.
Who cannot join
- none
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States12 sites
Study site
Charlottesville, Virginia, 22908
Study site
Chicago, Illinois, 60611
Study site
Cleveland, Ohio, 44195
Study site
Detroit, Michigan, 48201
Study site
Durham, North Carolina, 27710
Study site
Evanston, Illinois, 60201
Study site
New Brunswick, New Jersey, 08901
Study site
New York, New York, 10032
Study site
New York, New York, 10065
Study site
Pittsburgh, Pennsylvania, 15261
Study site
Rochester, New York, 14642
Study site
Somers Point, New Jersey, 08244
Italy7 sites
Study site
Bologna, 40138
Study site
Florence, 50134
Study site
Genova, 16132
Study site
Pisa, 56124
Study site
Roma, 168
Study site
Rome, 161
Study site
Udine, 33100
United Kingdom2 sites
Study site
Manchester, M239LT
Study site
Manchester, MI39WL
About this study
Official title: Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)
Read the detailed description
This multi-center, retrospective study of cases of serious bacterial infections (including cUTI or AP, HABP, VABP, and/or bacteremia caused by CRE) will consist of a chart review over a 6 month period from September 1, 2013 to March 1, 2014. De-identified data will be collected from the chart review of at least 150 cases of selected infections due to CRE at approximately 20 sites.
The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study.
Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.
- Conditions
- Urinary Tract Infection, Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia
- Medical subject headings
- Urinary Tract Infections, Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population
Measured: 6 month period from September 1, 2013 to March 1, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection, ComplicatedStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Fusaro, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420366
- Sponsor's protocol ID
- Rempex 506 NH
- Status last verified
- Apr 2018
- First submitted
- 8 Apr 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
- ClinicalTrials.gov ID
- NCT02420366
- Acronym / sponsor ID
- Rempex 506 NH
- Conditions
- Urinary Tract Infection, Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, Bacteremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Apr 2015 (estimated)
- 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.
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)
Detailed description
This multi-center, retrospective study of cases of serious bacterial infections (including cUTI or AP, HABP, VABP, and/or bacteremia caused by CRE) will consist of a chart review over a 6 month period from September 1, 2013 to March 1, 2014. De-identified data will be collected from the chart review of at least 150 cases of selected infections due to CRE at approximately 20 sites.
The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study.
Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with serious CRE infections identified by chart review at up to 20 sites
Key inclusion criteria (3 listed)
- Male or female ≥18 years of age.
- Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP, VABP, and/or bacteremia.
- Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia.
Key exclusion criteria (1 listed)
- none
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
Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population
Time frame: 6 month period from September 1, 2013 to March 1, 2014
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 2 May 2018.
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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.
Karen Fusaro study director
Sponsor GmbH
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection, Complicated and Acute Pyelonephritis, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) at 22 sites in 4 countries.
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 3 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: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Italy, United Kingdom, Greece. 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?
Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population (time frame: 6 month period from September 1, 2013 to March 1, 2014). 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 May 2018.