Carbapenemase-Producing EnterobacteriaceaeKPCNCT05492539
Incidence and Risk Factors for Developing Infections in Patients Colonized by CP-KPC
An observational study of Carbapenemase-Producing Enterobacteriaceae, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem. Infections caused by carbapenem-resistant Klebsiella pneumoniae (CR-KP) are associated with high morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Carbapenemase-Producing Enterobacteriaceae
- How many people
- 500 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2022to 3 Jun 2023
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized in an acute tertiary care university teaching hospital in Buenos Aires, Argentina
Who may be able to join
- Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized from 01/2014 to 01/2019
Who cannot join
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1181
Marina Valinoti, MD, +54 91149590200, marina.valinoti@hiba.org.ar
About this study
Official title: Incidence and Risk Factors for Developing Infections in Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
The worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem.
Infections caused by carbapenem-resistant Klebsiella pneumoniae (CR-KP) are associated with high morbidity and mortality. Mortality of up to 70% and, in survivors, a readmission rate of up to 72% within 90 days of discharge have been reported.
Read more
CR-KP infection is usually preceded by colonization. However, the incidence rate and risk factors for CR-KP infections among carriers is poorly understood.
Multiple studies have focused in risk factors to develop infections among carriers.
In order to identify patients at low risk of CR-KP bloodstream infections, Gianella et at developed a predictive score to stratify patients according to their risk for acquisition of CR-KP infections.
However, further studies are needed to validate these results, particularly in high-risk patients, such as haematological patients, solid organ trasplant recipients and patients admitted in ICU.
Italian Hospital is an acute tertiary care university teaching hospital with more than 45,000 admission-years, in Buenos Aires, Argentina, with a great proportion of haematological and solid organ transplant recipients, and patients with substantial comorbidities and immunosuppression.
With the aim of developing an adequate risk assessment for CR-KP infections among CR-KP carriers, we performed a retrospective cohort analysis, in a tertiary teaching hospital in Buenos Aires, Argentina.
The main purpose of our study is to describe the incidence of CR-KP infections among CRKP colonized patients, to demonstrate the risk factors for acquisition of CR-KP infections and to develop a clinical predictive score that could stratify patients to guide therapeutic decisions in CR-KP carriers, and avoid overuse of broad-spectrum therapy.
- Keywords
- Health Care Associated Infections; Carbapenemase-Producing Enterobacteriaceae; colonization status, Risk Factors
- Medical subject headings
- Cross Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
CRKP infections in CRKP colonized patients
the presence of a positive clinical culture of CR-KP, a documented physician diagnosis, and the initiation of targeted antimicrobial therapy.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
30 day all-cause mortality
30-day mortality rate starting from the date the relevant clinical culture was obtained.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jul 2022
- Primary completion1 May 2023 (estimated)
- Study completion3 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carbapenemase-Producing EnterobacteriaceaeStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARINA VALINOTI, Hospital Italiano de Buenos Aires
- Investigators
- Marina Valinoti, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492539
- Sponsor's protocol ID
- 3978
- Acronym
- KPC
- Status last verified
- Feb 2023
- First submitted
- 4 Aug 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giannella M, Trecarichi EM, De Rosa FG, Del Bono V, Bassetti M, Lewis RE, Losito AR, Corcione S, Saffioti C, Bartoletti M, Maiuro G, Cardellino CS, Tedeschi S, Cauda R, Viscoli C, Viale P, Tumbarello M. Risk factors for carbapenem-resistant Klebsiella pneumoniae bloodstream infection among rectal carriers: a prospective observational multicentre study. Clin Microbiol Infect. 2014 Dec;20(12):1357-62. doi: 10.1111/1469-0691.12747. Epub 2014 Aug 11.
PubMed 24980276Gutierrez-Gutierrez B, Salamanca E, de Cueto M, Hsueh PR, Viale P, Pano-Pardo JR, Venditti M, Tumbarello M, Daikos G, Pintado V, Doi Y, Tuon FF, Karaiskos I, Machuca I, Schwaber MJ, Azap OK, Souli M, Roilides E, Pournaras S, Akova M, Perez F, Bermejo J, Oliver A, Almela M, Lowman W, Almirante B, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J; Investigators from the REIPI/ESGBIS/INCREMENT Group. A Predictive Model of Mortality in Patients With Bloodstream Infections due to Carbapenemase-Producing Enterobacteriaceae. Mayo Clin Proc. 2016 Oct;91(10):1362-1371. doi: 10.1016/j.mayocp.2016.06.024.
PubMed 27712635Ny P, Nieberg P, Wong-Beringer A. Impact of carbapenem resistance on epidemiology and outcomes of nonbacteremic Klebsiella pneumoniae infections. Am J Infect Control. 2015 Oct 1;43(10):1076-80. doi: 10.1016/j.ajic.2015.06.008. Epub 2015 Jul 17.
PubMed 26190386
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Developing Infections in Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
- ClinicalTrials.gov ID
- NCT05492539
- Acronym / sponsor ID
- KPC / 3978
- Keywords
- Health Care Associated Infections; Carbapenemase-Producing Enterobacteriaceae; colonization status, Risk Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 3 Jun 2023 (estimated)
- First posted
- 8 Aug 2022 (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.
The worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem.
Infections caused by carbapenem-resistant Klebsiella pneumoniae (CR-KP) are associated with high morbidity and mortality. Mortality of up to 70% and, in survivors, a readmission rate of up to 72% within 90 days of discharge have been reported.
CR-KP infection is usually preceded by colonization. However, the incidence rate and risk factors for CR-KP infections among carriers is poorly understood.
Multiple studies have focused in risk factors to develop infections among carriers.
In order to identify patients at low risk of CR-KP bloodstream infections, Gianella et at developed a predictive score to stratify patients according to their risk for acquisition of CR-KP infections.
However, further studies are needed to validate these results, particularly in high-risk patients, such as haematological patients, solid organ trasplant recipients and patients admitted in ICU.
Italian Hospital is an acute tertiary care university teaching hospital with more than 45,000 admission-years, in Buenos Aires, Argentina, with a great proportion of haematological and solid organ transplant recipients, and patients with substantial comorbidities and immunosuppression.
With the aim of developing an adequate risk assessment for CR-KP infections among CR-KP carriers, we performed a retrospective cohort analysis, in a tertiary teaching hospital in Buenos Aires, Argentina.
The main purpose of our study is to describe the incidence of CR-KP infections among CRKP colonized patients, to demonstrate the risk factors for acquisition of CR-KP infections and to develop a clinical predictive score that could stratify patients to guide therapeutic decisions in CR-KP carriers, and avoid overuse of broad-spectrum therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized in an acute tertiary care university teaching hospital in Buenos Aires, Argentina
Key inclusion criteria (1 listed)
- Adult (≥18 years) patients with a CR-KP positive rectal swab, hospitalized from 01/2014 to 01/2019
Key exclusion criteria (1 listed)
- Unwillingness to participate
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
CRKP infections in CRKP colonized patients
Time frame: through study completion, an average of 1 year
the presence of a positive clinical culture of CR-KP, a documented physician diagnosis, and the initiation of targeted antimicrobial therapy.
1 secondary outcome
30 day all-cause mortality
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Results publication: PubMed 24980276Giannella M, Trecarichi EM, De Rosa FG, Del Bono V, Bassetti M, Lewis RE, Losito AR, Corcione S, Saffioti C, Bartoletti M, Maiuro G, Cardellino CS, Tedeschi S, Cauda R, Viscoli C, Viale P, Tumbarello M. Risk factors for carbapenem-resistant Klebsiella pneumoniae bloodstream infection among rectal carriers: a prospective observational multicentre study. Clin Microbiol Infect. 2014 Dec;20(12):1357-62. doi: 10.1111/1469-0691.12747. Epub 2014 Aug 11.
- Results publication: PubMed 27712635Gutierrez-Gutierrez B, Salamanca E, de Cueto M, Hsueh PR, Viale P, Pano-Pardo JR, Venditti M, Tumbarello M, Daikos G, Pintado V, Doi Y, Tuon FF, Karaiskos I, Machuca I, Schwaber MJ, Azap OK, Souli M, Roilides E, Pournaras S, Akova M, Perez F, Bermejo J, Oliver A, Almela M, Lowman W, Almirante B, Bonomo RA, Carmeli Y, Paterson DL, Pascual A, Rodriguez-Bano J; Investigators from the REIPI/ESGBIS/INCREMENT Group. A Predictive Model of Mortality in Patients With Bloodstream Infections due to Carbapenemase-Producing Enterobacteriaceae. Mayo Clin Proc. 2016 Oct;91(10):1362-1371. doi: 10.1016/j.mayocp.2016.06.024.
- Results publication: PubMed 26190386Ny P, Nieberg P, Wong-Beringer A. Impact of carbapenem resistance on epidemiology and outcomes of nonbacteremic Klebsiella pneumoniae infections. Am J Infect Control. 2015 Oct 1;43(10):1076-80. doi: 10.1016/j.ajic.2015.06.008. Epub 2015 Jul 17.
- 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.
Marina Valinoti, MD principal investigator
Hospital Italiano de Buenos Aires
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 Carbapenemase-Producing Enterobacteriaceae, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 28 Feb 2023. 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 Argentina. 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?
Contact Marina Valinoti, MD (+541166631624, marina.valinoti@hiba.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRKP infections in CRKP colonized patients (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492539, which also lists 3 linked publications.
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 28 Feb 2023.