Healthcare-Associated Infections (HAIs)CPE-Load ICU SNCT07685132
Correlation Between Carbapenemase-Producing Enterobacterales Load, Environmental Contamination, and Transmission in Critical Care Units
An observational study of Healthcare-Associated Infections (HAIs) and Carbapenem-Resistant Enterobacteriaceae Colonization, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare-Associated Infections (HAIs), Carbapenem-Resistant Enterobacteriaceae Colonization, Antimicrobial Resistance (AMR)
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Aug 2026to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients hospitalized in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires during the study period, with a positive surveillance rectal swab for carbapenemase-producing Enterobacterales detected through the institutional infection control surveillance program.
Who may be able to join
- Age 18 years or older.
- Hospitalized in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires during the study period.
- Positive surveillance rectal swab for carbapenemase-producing Enterobacterales.
Who cannot join
- -Patients colonized or infected with carbapenemase-producing Enterobacterales who remained in the same room for less than 48 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Ines Staneloni, MD contact
Emilio Felipe Huaier Arriazu, MD contact
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., 1199
Emilio Felipe Huaier Arriazu, MD, +549 011-49590200 ext. 8165 / 9542, emilio.huaier@hospitalitaliano.org.ar
CCI Comité de Control de Infecciones, MD, +54911-49590200 ext. 8165 / 9542, comite.infecciones@hospitalitaliano.org.ar
About this study
Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs). Some colonized individuals may carry a particularly high bacterial burden and contribute disproportionately to environmental contamination and transmission to other patients. Identifying these high-risk individuals could improve infection prevention and control strategies.
This prospective observational study will be conducted in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires. Patients identified as colonized with CPE through routine surveillance will undergo quantitative culture and real-time polymerase chain reaction (PCR) testing of rectal swabs to measure bacterial load. Environmental samples will also be collected from high-touch surfaces surrounding colonized patients. In selected cases, molecular typing methods will be used to evaluate genetic relatedness between patient and environmental isolates and to investigate possible transmission events.
The primary objective is to determine the correlation between bacterial load measured by culture and the PCR cycle threshold (Ct) value. Secondary objectives include evaluating the association between bacterial load and environmental contamination, and assessing whether patients with higher bacterial loads are more likely to contribute to transmission within the ICU. Results may help identify patients with increased dissemination potential and support targeted infection prevention interventions.
Read the detailed description
Carbapenemase-producing Enterobacterales (CPE) represent a major global public health threat because of their extensive antimicrobial resistance and their ability to spread within healthcare facilities. Gastrointestinal colonization is recognized as the main reservoir for transmission. Previous studies have suggested that a subset of colonized patients, often referred to as "super-spreaders," carry a substantially higher bacterial burden and may account for a disproportionate share of environmental contamination and transmission events.
Although bacterial load can be quantified using culture-based and molecular methods, there is currently no validated cycle threshold (Ct) value from routinely used real-time PCR assays that reliably identifies patients with high dissemination potential. Establishing a correlation between Ct values and bacterial burden could provide a practical and accessible tool for infection prevention programs.
This prospective observational cohort study will be conducted in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires. All patients identified through the institutional surveillance program as colonized with CPE will be eligible for inclusion. For each CPE-positive patient, rectal swabs obtained as part of routine surveillance will undergo quantitative culture on selective chromogenic media and molecular testing using real-time PCR targeting carbapenemase genes. Bacterial load will be estimated using colony-forming unit counts and PCR Ct values.
Environmental contamination will be assessed through systematic sampling of high-touch surfaces in the patient's surroundings, including bed linen, bedside furniture, and medical equipment. Environmental isolates will undergo microbiological and molecular characterization. In selected situations, whole genome sequencing or pulsed-field gel electrophoresis will be performed to evaluate genetic relatedness among isolates recovered from patients, environmental samples, and secondary cases.
The primary outcome is the correlation between quantitative bacterial load and PCR Ct values. Secondary outcomes include the extent of environmental contamination associated with different bacterial loads and the occurrence of transmission events involving genetically related strains. Multivariable analyses will evaluate the influence of relevant clinical and epidemiological factors, including length of stay, fecal incontinence, prior antimicrobial exposure, immunosuppression, and other potential confounders.
The study involves minimal risk because all patient samples are obtained within the framework of routine infection control surveillance. Findings from this study may improve the identification of patients with increased transmission potential and support more targeted and efficient infection prevention strategies in critical care settings.
- Conditions
- Healthcare-Associated Infections (HAIs), Carbapenem-Resistant Enterobacteriaceae Colonization, Antimicrobial Resistance (AMR)
- Keywords
- Carbapenemase-Producing Enterobacterales, CPE, Colonization, Super-Spreader, Cycle Threshold, Ct Value, Real-Time PCR, Environmental Contamination, Nosocomial Transmission, Infection Prevention and Control, Intensive Care Unit, Multidrug Resistance, Antimicrobial Resistance
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CPE-Colonized ICU Patients | Patients admitted to the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires with a positive surveillance rectal swab for carbapenemase-producing Enterobacterales (CPE). Participants will undergo quantitative culture and real-time PCR testing of rectal swabs as part of routine surveillance. Environmental samples will be collected from high-touch surfaces surrounding colonized patients to evaluate environmental contamination and transmission dynamics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between PCR Cycle Threshold (Ct) Value and Quantitative Bacterial Load (CFU/swab) in Rectal Surveillance Swabs
Spearman correlation coefficient between the cycle threshold (Ct) value obtained by real-time PCR (BD MAX™ system) targeting carbapenemase genes and the quantitative bacterial load measured by culture on CHROMagar™ KPC selective medium, expressed as colony-forming units per swab (CFU/swab), from rectal surveillance swabs positive for carbapenemase-producing Enterobacterales.
Measured: At baseline (time of positive rectal surveillance swab)
Secondary outcomes (6)
Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces
Spearman correlation coefficient between the quantitative bacterial load of carbapenemase-producing Enterobacterales in rectal surveillance swabs, measured by culture on CHROMagar™ KPC selective medium and expressed as colony-forming units per swab (CFU/swab), and the number of CPE-positive high-touch surfaces out of 5 sampled (bed linen, bedside table, and infusion pump), assessed by quantitative culture on CHROMagar™ KPC contact plates.
Measured: Within 24 hours of rectal swab collection
Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces
Spearman correlation coefficient between the cycle threshold (Ct) value obtained by real-time PCR (BD MAX™ system) targeting carbapenemase genes from rectal surveillance swabs positive for carbapenemase-producing Enterobacterales, and the number of CPE-positive high-touch surfaces out of 5 sampled (bed linen, bedside table, and infusion pump), assessed by quantitative culture on CHROMagar™ KPC contact plates.
Measured: Within 24 hours of rectal swab collection
Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces
Spearman correlation coefficient between the quantitative bacterial load of carbapenemase-producing Enterobacterales in rectal surveillance swabs, measured by culture on CHROMagar™ KPC selective medium and expressed as colony-forming units per swab (CFU/swab), and the total colony-forming units (CFU) recovered across five high-touch surfaces (bed linen, bedside table, and infusion pump) surrounding colonized patients, assessed by quantitative culture on CHROMagar™ KPC contact plates.
Measured: Within 24 hours of rectal swab collection
Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces
Spearman correlation coefficient between the cycle threshold (Ct) value obtained by real-time PCR (BD MAX™ system) targeting carbapenemase genes from rectal surveillance swabs positive for carbapenemase-producing Enterobacterales, and the total colony-forming units (CFU) recovered across five high-touch surfaces (bed linen, bedside table, and infusion pump) surrounding colonized patients, assessed by quantitative culture on CHROMagar™ KPC contact plates.
Measured: Within 24 hours of rectal swab collection
Number of Index Patients with Transmission of at Least One Genetically Related CPE Strain to a Co-Hospitalized Patient
Number of index patients associated with at least one secondary case carrying a genetically related carbapenemase-producing Enterobacterales strain, confirmed by whole genome sequencing (WGS) and/or pulsed-field gel electrophoresis (PFGE), among patients hospitalized in the same intensive care unit during the study period.
Measured: Up to 6 months
Number of Patients Meeting Predefined Criteria for Super-Spreader Classification
Number of CPE-colonized patients classified as potential super-spreaders, defined post-hoc as having a cycle threshold (Ct) value below the 25th percentile of the study population and at least 2 positive environmental surfaces with more than 50 colony-forming units (CFU) each, assessed by quantitative culture on CHROMagar™ KPC contact plates.
Measured: At baseline (time of CPE detection and environmental sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthcare-Associated Infections (HAIs)Studies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina
- Responsible party
- Principal investigator, MARIA INES STANELONI, Hospital Italiano de Buenos Aires
- Investigators
- Maria Ines Staneloni, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685132
- Sponsor's protocol ID
- 7703
- Acronym
- CPE-Load ICU S
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results reported in publications will be available after de-identification. Data may be shared with qualified researchers upon reasonable request to the principal investigator and after approval by the Hospital Italiano de Buenos Aires Ethics Committee, in accordance with institutional policies and applicable regulations regarding data protection and patient confidentiality. What IPD Will Be Shared? De-identified demographic data Clinical characteristics Rectal swab quantitative culture results PCR cycle threshold (Ct) values Environmental sampling results Molecular characterization and genomic data used in analyses Derived study variables
Publications
Tenover FC, Arbeit RD, Goering RV, Mickelsen PA, Murray BE, Persing DH, Swaminathan B. Interpreting chromosomal DNA restriction patterns produced by pulsed-field gel electrophoresis: criteria for bacterial strain typing. J Clin Microbiol. 1995 Sep;33(9):2233-9. doi: 10.1128/jcm.33.9.2233-2239.1995. No abstract available.
PubMed 7494007Gomez SA, Pasteran FG, Faccone D, Tijet N, Rapoport M, Lucero C, Lastovetska O, Albornoz E, Galas M; KPC Group; Melano RG, Corso A, Petroni A. Clonal dissemination of Klebsiella pneumoniae ST258 harbouring KPC-2 in Argentina. Clin Microbiol Infect. 2011 Oct;17(10):1520-4. doi: 10.1111/j.1469-0691.2011.03600.x. Epub 2011 Aug 18.
PubMed 21851480Wei M, Chen X, Liu J, Li T, Wang P, Wang S, Wang J, Gu L. Development and Validation of a Novel Multiplex Real-Time PCR Assay for Rapid Detection of Carbapenemase Genes in Carbapenem-Resistant Enterobacterales Isolates and Clinical Samples. Infect Drug Resist. 2024 Aug 9;17:3451-3462. doi: 10.2147/IDR.S475630. eCollection 2024.
PubMed 39139626Lerner A, Romano J, Chmelnitsky I, Navon-Venezia S, Edgar R, Carmeli Y. Rectal swabs are suitable for quantifying the carriage load of KPC-producing carbapenem-resistant Enterobacteriaceae. Antimicrob Agents Chemother. 2013 Mar;57(3):1474-9. doi: 10.1128/AAC.01275-12. Epub 2013 Jan 7.
PubMed 23295937Lerner A, Adler A, Abu-Hanna J, Cohen Percia S, Kazma Matalon M, Carmeli Y. Spread of KPC-producing carbapenem-resistant Enterobacteriaceae: the importance of super-spreaders and rectal KPC concentration. Clin Microbiol Infect. 2015 May;21(5):470.e1-7. doi: 10.1016/j.cmi.2014.12.015. Epub 2014 Dec 26.
PubMed 25684452
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Carbapenemase-Producing Enterobacterales Load, Environmental Contamination, and Transmission in Critical Care Units
- ClinicalTrials.gov ID
- NCT07685132
- Acronym / sponsor ID
- CPE-Load ICU S / 7703
- Conditions
- Healthcare-Associated Infections (HAIs), Carbapenem-Resistant Enterobacteriaceae Colonization, Antimicrobial Resistance (AMR)
- Keywords
- Carbapenemase-Producing Enterobacterales, CPE, Colonization, Super-Spreader, Cycle Threshold, Ct Value, Real-Time PCR, Environmental Contamination
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 6 Jul 2026 (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.
Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs). Some colonized individuals may carry a particularly high bacterial burden and contribute disproportionately to environmental contamination and transmission to other patients. Identifying these high-risk individuals could improve infection prevention and control strategies.
This prospective observational study will be conducted in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires. Patients identified as colonized with CPE through routine surveillance will undergo quantitative culture and real-time polymerase chain reaction (PCR) testing of rectal swabs to measure bacterial load. Environmental samples will also be collected from high-touch surfaces surrounding colonized patients. In selected cases, molecular typing methods will be used to evaluate genetic relatedness between patient and environmental isolates and to investigate possible transmission events.
The primary objective is to determine the correlation between bacterial load measured by culture and the PCR cycle threshold (Ct) value. Secondary objectives include evaluating the association between bacterial load and environmental contamination, and assessing whether patients with higher bacterial loads are more likely to contribute to transmission within the ICU. Results may help identify patients with increased dissemination potential and support targeted infection prevention interventions.
Detailed description
Carbapenemase-producing Enterobacterales (CPE) represent a major global public health threat because of their extensive antimicrobial resistance and their ability to spread within healthcare facilities. Gastrointestinal colonization is recognized as the main reservoir for transmission. Previous studies have suggested that a subset of colonized patients, often referred to as "super-spreaders," carry a substantially higher bacterial burden and may account for a disproportionate share of environmental contamination and transmission events.
Although bacterial load can be quantified using culture-based and molecular methods, there is currently no validated cycle threshold (Ct) value from routinely used real-time PCR assays that reliably identifies patients with high dissemination potential. Establishing a correlation between Ct values and bacterial burden could provide a practical and accessible tool for infection prevention programs.
This prospective observational cohort study will be conducted in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires. All patients identified through the institutional surveillance program as colonized with CPE will be eligible for inclusion. For each CPE-positive patient, rectal swabs obtained as part of routine surveillance will undergo quantitative culture on selective chromogenic media and molecular testing using real-time PCR targeting carbapenemase genes. Bacterial load will be estimated using colony-forming unit counts and PCR Ct values.
Environmental contamination will be assessed through systematic sampling of high-touch surfaces in the patient's surroundings, including bed linen, bedside furniture, and medical equipment. Environmental isolates will undergo microbiological and molecular characterization. In selected situations, whole genome sequencing or pulsed-field gel electrophoresis will be performed to evaluate genetic relatedness among isolates recovered from patients, environmental samples, and secondary cases.
The primary outcome is the correlation between quantitative bacterial load and PCR Ct values. Secondary outcomes include the extent of environmental contamination associated with different bacterial loads and the occurrence of transmission events involving genetically related strains. Multivariable analyses will evaluate the influence of relevant clinical and epidemiological factors, including length of stay, fecal incontinence, prior antimicrobial exposure, immunosuppression, and other potential confounders.
The study involves minimal risk because all patient samples are obtained within the framework of routine infection control surveillance. Findings from this study may improve the identification of patients with increased transmission potential and support more targeted and efficient infection prevention strategies in critical care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPE-Colonized ICU Patients | – | –Patients admitted to the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires with a positive surveillance rectal swab for carbapenemase-producing Enterobacterales (CPE). Participants will undergo quantitative culture and real-time PCR testing of rectal swabs as part of routine surveillance. Environmental samples will be collected from high-touch surfaces surrounding colonized patients to evaluate environmental contamination and transmission dynamics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires during the study period, with a positive surveillance rectal swab for carbapenemase-producing Enterobacterales detected through the institutional infection control surveillance program.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Hospitalized in the Adult Intensive Care Unit of Hospital Italiano de Buenos Aires during the study period.
- Positive surveillance rectal swab for carbapenemase-producing Enterobacterales.
Key exclusion criteria (1 listed)
- -Patients colonized or infected with carbapenemase-producing Enterobacterales who remained in the same room for less than 48 hours.
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
Correlation Between PCR Cycle Threshold (Ct) Value and Quantitative Bacterial Load (CFU/swab) in Rectal Surveillance Swabs
Time frame: At baseline (time of positive rectal surveillance swab)
Spearman correlation coefficient between the cycle threshold (Ct) value obtained by real-time PCR (BD MAX™ system) targeting carbapenemase genes and the quantitative bacterial load measured by culture on CHROMagar™ KPC selective medium, expressed as colony-forming units per swab (CFU/swab), from rectal surveillance swabs positive for carbapenemase-producing Enterobacterales.
6 secondary outcomes
Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces
Time frame: Within 24 hours of rectal swab collection
Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Number of CPE-Positive High-Touch Environmental Surfaces
Time frame: Within 24 hours of rectal swab collection
Correlation Between Quantitative Bacterial Load (CFU/swab) in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces
Time frame: Within 24 hours of rectal swab collection
Correlation Between PCR Cycle Threshold (Ct) Value in Rectal Swabs and Total Colony-Forming Units Recovered from Environmental Surfaces
Time frame: Within 24 hours of rectal swab collection
Number of Index Patients with Transmission of at Least One Genetically Related CPE Strain to a Co-Hospitalized Patient
Time frame: Up to 6 months
Number of Patients Meeting Predefined Criteria for Super-Spreader Classification
Time frame: At baseline (time of CPE detection and environmental sampling)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 7494007Tenover FC, Arbeit RD, Goering RV, Mickelsen PA, Murray BE, Persing DH, Swaminathan B. Interpreting chromosomal DNA restriction patterns produced by pulsed-field gel electrophoresis: criteria for bacterial strain typing. J Clin Microbiol. 1995 Sep;33(9):2233-9. doi: 10.1128/jcm.33.9.2233-2239.1995. No abstract available.
- Background: PubMed 21851480Gomez SA, Pasteran FG, Faccone D, Tijet N, Rapoport M, Lucero C, Lastovetska O, Albornoz E, Galas M; KPC Group; Melano RG, Corso A, Petroni A. Clonal dissemination of Klebsiella pneumoniae ST258 harbouring KPC-2 in Argentina. Clin Microbiol Infect. 2011 Oct;17(10):1520-4. doi: 10.1111/j.1469-0691.2011.03600.x. Epub 2011 Aug 18.
- Background: PubMed 39139626Wei M, Chen X, Liu J, Li T, Wang P, Wang S, Wang J, Gu L. Development and Validation of a Novel Multiplex Real-Time PCR Assay for Rapid Detection of Carbapenemase Genes in Carbapenem-Resistant Enterobacterales Isolates and Clinical Samples. Infect Drug Resist. 2024 Aug 9;17:3451-3462. doi: 10.2147/IDR.S475630. eCollection 2024.
- Background: PubMed 23295937Lerner A, Romano J, Chmelnitsky I, Navon-Venezia S, Edgar R, Carmeli Y. Rectal swabs are suitable for quantifying the carriage load of KPC-producing carbapenem-resistant Enterobacteriaceae. Antimicrob Agents Chemother. 2013 Mar;57(3):1474-9. doi: 10.1128/AAC.01275-12. Epub 2013 Jan 7.
- Background: PubMed 25684452Lerner A, Adler A, Abu-Hanna J, Cohen Percia S, Kazma Matalon M, Carmeli Y. Spread of KPC-producing carbapenem-resistant Enterobacteriaceae: the importance of super-spreaders and rectal KPC concentration. Clin Microbiol Infect. 2015 May;21(5):470.e1-7. doi: 10.1016/j.cmi.2014.12.015. Epub 2014 Dec 26.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results reported in publications will be available after de-identification. Data may be shared with qualified researchers upon reasonable request to the principal investigator and after approval by the Hospital Italiano de Buenos Aires Ethics Committee, in accordance with institutional policies and applicable regulations regarding data protection and patient confidentiality. What IPD Will Be Shared? De-identified demographic data Clinical characteristics Rectal swab quantitative culture results PCR cycle threshold (Ct) values Environmental sampling results Molecular characterization and genomic data used in analyses Derived study variables
Related trials for Healthcare-Associated Infections (HAIs)
Active, not recruitingObservational study
Prevalence of Multidrug-Resistant Organism Infections in General Adult Wards in Argentina (PREV-AR 2 - IGA)
Multidrug-Resistant Organism Infection, Healthcare-Associated Infections (HAIs)
Recruiting
Effectiveness of an Edge AI-based Augmented Reality System for Hand Hygiene Training: a Multi-centre, Mixed-methods Cluster Randomised Controlled Trial
Hand Hygiene Training, Infection Prevention and Control
Enrolling by invitation
Effect of Daily Chlorhexidine Bathing and Antibiotic/PPI Stewardship on Prevention of CPE Transmission and Infection
Carbapenemase-Producing Enterobacteriaceae (CPE), Healthcare-Associated Infections (HAIs)
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.
Maria Ines Staneloni, MD contact
Emilio Felipe Huaier Arriazu, MD contact
Maria Ines Staneloni, 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 Healthcare-Associated Infections (HAIs) and Carbapenem-Resistant Enterobacteriaceae Colonization, 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 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Ines Staneloni, MD (+549 011 49590200 ext. 8165 / 9542, maria.staneloni@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between PCR Cycle Threshold (Ct) Value and Quantitative Bacterial Load (CFU/swab) in Rectal Surveillance Swabs (time frame: At baseline (time of positive rectal surveillance swab)). 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 NCT07685132, which also lists 5 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 6 Jul 2026.