CirrhosisNCT06634940
International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
An observational study of Cirrhosis and Bacterial Infections, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
What is this study about? This study tracks antibiotic resistance in patients with cirrhosis who develop bacterial infections. Cirrhosis is a condition where the liver is severely scarred, and people with cirrhosis are at high risk for serious bacterial infections. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Cirrhosis, Bacterial Infections, Multidrug Resistance
- How many people
- 1,000 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Nov 2020to 1 Jun 2031
- How long will I take part?
- 1 Week
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients in Latin American countries
Who may be able to join
- Episodes of culture-confirmed bacterial infections
- Patients diagnosed with cirrhosis
- Infections diagnosed either at the time of hospital admission or during hospitalization
Who cannot join
- History of solid organ or hematopoietic stem cell transplantation
- Declined to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastián M Marciano, Principal Investigator. contact
Gonzalo Gomez Perdiguero, Registry coordinator contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1199ABB.
Sebastián Marciano, Principal Investigator, MD, 54 11 49590200 ext. 5370, sebastian.marciano@hospitalitaliano.org.ar
Gonzalo Gomez Perdiguero, Subinvestigator, MD, 54 11 49590200 ext. 5370, gonzalo.gomez@hospitalitaliano.org.ar
About this study
What is this study about?
This study tracks antibiotic resistance in patients with cirrhosis who develop bacterial infections. Cirrhosis is a condition where the liver is severely scarred, and people with cirrhosis are at high risk for serious bacterial infections.
Read more
Why is this study important?
Bacterial infections are common in patients with cirrhosis, affecting 25-46% of those who are hospitalized. These infections can be life-threatening, with 1 in 4 patients dying from complications. Many of these infections are becoming harder to treat because the bacteria are resistant to antibiotics. Infections caused by resistant bacteria are increasing, which makes finding the right antibiotic quickly even more difficult.
In other regions of the world, guidelines exist to help doctors choose the right antibiotics for cirrhosis patients. However, in Latin America, we don't have specific guidelines for our region, and doctors currently rely on recommendations from the U.S. or Europe. These guidelines may not reflect the local patterns of bacterial infections and resistance we see here.
What is the goal of this study?
The main goal of this study is to create a long-term system to track how bacteria respond to antibiotics in patients with cirrhosis in Latin America. By collecting data from hospitals across different countries, we aim to:
- Identify how many infections are caused by multidrug-resistant bacteria.
- Understand how antibiotics (such as ceftriaxone, vancomycin, and carbapenems) act against these infections.
- Generate reports informing bacterial resistance patterns to help doctors make better patient treatment decisions.
What do we hope to achieve?
We hope the data we collect will help develop guidelines for patients with cirrhosis in Latin America. These guidelines will ensure that doctors use the most effective antibiotics based on real-time data from our region. This should improve patient outcomes and help prevent the spread of resistant bacteria.
Read the detailed description
Bacterial infections are among the most common complications in patients with cirrhosis, affecting 25-46% of those hospitalized. In two-thirds of cases, these infections are diagnosed during hospitalization, while the remainder develop during the hospital stay. The high mortality rate associated with these infections is significant, with one in four patients succumbing to the complication.
Regarding origin, 30-35% of bacterial infections in patients with cirrhosis are classified as spontaneous, with the rest being non-spontaneous. Spontaneous bacterial peritonitis is the most frequently reported infection specific to patients with cirrhosis and portal hypertension. Other spontaneous infections include spontaneous bacteremia and spontaneous bacterial empyema.
A significant factor influencing patient outcomes in bacterial infections is the rapid initiation of appropriate empirical antibiotic therapy. It is generally recommended that empirical treatment covers 80% of expected bacteria in stable patients and 90% in critically ill patients. However, this goal is increasingly challenging due to shifting epidemiology, with a rise in Gram-positive organisms and a growing incidence of multidrug resistance. Recent studies have shown that 34% of infections in patients with cirrhosis are caused by multidrug-resistant microorganisms, which are linked to poorer outcomes, complicating patient management, and increasing healthcare costs.
Although guidelines for empirical antibiotic treatment exist in other regions, none have been developed for Latin America. As a result, clinicians often rely on recommendations from the United States or Europe, which may not accurately reflect the epidemiology in this region.
GENERAL OBJECTIVES
- To establish and sustain a surveillance system to monitor the antibiotic susceptibility patterns of microorganisms responsible for infections in patients with cirrhosis.
- To produce periodic reports on evolving resistance patterns of microorganisms involved in infections in patients with cirrhosis.
EXPECTED OUTCOMES
This project aligns with global strategies to address the rise in infections caused by multidrug-resistant microorganisms. By applying a research methodology based on international standards, the study aims to ensure the collection of high-quality data that can lead to actionable outcomes.
Our research team initiated this project in 2020 to create a continuous surveillance program for bacterial infections in cirrhosis patients within our region. The goal is to collect and share real-time data on antibiotic susceptibility patterns.
We expect to generate results that will enable the production of detailed reports on the susceptibility patterns of bacterial infections in patients with cirrhosis at different levels. This will provide the necessary information to develop region-specific guidelines for the appropriate use of empirical antibiotics in this population. Additionally, periodic updates will reflect ongoing epidemiological changes.
---
This structure improves the flow and maintains a scientific tone. Let me know if further revisions are needed!
- Conditions
- Cirrhosis, Bacterial Infections, Multidrug Resistance
- Keywords
- antibiotics, empirical treatment, methicillin-resistant Staphylococcus aureus, extended-spectrum beta-lactamase-producing organisms, Carbapenemase-Producing Enterobacteriaceae, de-escalation, guidelines, empiric antibiotics
- Medical subject headings
- Fibrosis, Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of multidrug-resistant organisms
Estimated by using the total number of bacterial infection episodes involving at least one multidrug-resistant organism as the numerator and the total number of bacterial infection episodes as the denominator.
Measured: 1 week
Proportion of extensively drug-resistant microorganisms
Estimated by using the total number of bacterial infection episodes involving at least one extensively drug-resistant microorganism as the numerator and the total number of bacterial infection episodes as the denominator.
Measured: 1 week
Proportion of pan drug-resistant microorganisms
Estimated by using the total number of bacterial infection episodes involving at least one pan drug-resistant microorganism as the numerator and the total number of bacterial infection episodes as the denominator.
Measured: 1 week
Secondary outcomes (20)
Proportion of episodes on infection susceptible to quinolones
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to quinolones as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to quinolones for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to nitrofurantoin
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to nitrofurantoin as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to nitrofurantoin for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to Trimethoprim-Sulfamethoxazole
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to Trimethoprim-Sulfamethoxazole as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to Trimethoprim-Sulfamethoxazole for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to ceftriaxone
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to ceftriaxone as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to ceftriaxone for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to ceftazidime
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to ceftazidime as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to ceftazidime for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to cefepime
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to cefepime as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to cefepime for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to aminoglycosides
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to aminoglycosides as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to aminoglycosides for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to piperacillin-tazobactam
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to piperacillin-tazobactam as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to piperacillin-tazobactam for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to ertapenem
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to ertapenem as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to ertapenem for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to meropenem/imipenem
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to meropenem or imipenem as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to meropenem or imipenem for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to colistin:
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to colistin as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to colistin for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to ceftazidime-avibactam
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to ceftazidime-avibactam as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to ceftazidime-avibactam for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to ceftolozane-tazobactam
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to ceftolozane-tazobactam as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to ceftolozane-tazobactam for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to piperacillin-tazobactam plus vancomycin
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to piperacillin-tazobactam or vancomycin as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to at least one of the antibiotics for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to carbapenem plus vancomycin
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to both carbapenem and vancomycin as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to both antibiotics for the episode to be considered susceptible
Measured: 1 week
Proportion of episodes of infection susceptible to carbapenem plus linezolid
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to carbapenems or linezolid as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to at least one of the antibiotics for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to carbapenem + linezolid
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to either carbapenem or linezolid as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to at least one of the antibiotics for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to aminoglycoside + colistin
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to either aminoglycoside or colistin as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to at least one of the antibiotics for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to ceftazidime-avibactam + aztreonam
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to either ceftazidime-avibactam or aztreonam as the numerator and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to at least one of the antibiotics for the episode to be considered susceptible.
Measured: 1 week
Proportion of episodes of infection susceptible to ceftazidime-avibactam + vancomycin
Estimated by using the total number of bacterial infection episodes involving microorganisms with in vitro susceptibility to either ceftazidime-avibactam or vancomycin as the numerator, and the total number of bacterial infection episodes as the denominator. For episodes involving more than one organism, all organisms must be susceptible to at least one of the antibiotics for the episode to be considered susceptible
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Nov 2020
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEBASTIAN MARCIANO. MD, MsC, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634940
- Sponsor's protocol ID
- 5821
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I am willing to share individual participant data based on the proposal, the project's relevance and importance, and ensuring data security
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Surveillance of Antimicrobial Resistance in Cirrhosis-Related Infections
- ClinicalTrials.gov ID
- NCT06634940
- Acronym / sponsor ID
- 5821
- Conditions
- Cirrhosis, Bacterial Infections, Multidrug Resistance
- Keywords
- antibiotics, empirical treatment, methicillin-resistant Staphylococcus aureus, extended-spectrum beta-lactamase-producing organisms, Carbapenemase-Producing Enterobacteriaceae, de-escalation, guidelines, empiric antibiotics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 10 Oct 2024 (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.
What is this study about?
This study tracks antibiotic resistance in patients with cirrhosis who develop bacterial infections. Cirrhosis is a condition where the liver is severely scarred, and people with cirrhosis are at high risk for serious bacterial infections.
Why is this study important?
Bacterial infections are common in patients with cirrhosis, affecting 25-46% of those who are hospitalized. These infections can be life-threatening, with 1 in 4 patients dying from complications. Many of these infections are becoming harder to treat because the bacteria are resistant to antibiotics. Infections caused by resistant bacteria are increasing, which makes finding the right antibiotic quickly even more difficult.
In other regions of the world, guidelines exist to help doctors choose the right antibiotics for cirrhosis patients. However, in Latin America, we don't have specific guidelines for our region, and doctors currently rely on recommendations from the U.S. or Europe. These guidelines may not reflect the local patterns of bacterial infections and resistance we see here.
What is the goal of this study?
The main goal of this study is to create a long-term system to track how bacteria respond to antibiotics in patients with cirrhosis in Latin America. By collecting data from hospitals across different countries, we aim to:
- Identify how many infections are caused by multidrug-resistant bacteria.
- Understand how antibiotics (such as ceftriaxone, vancomycin, and carbapenems) act against these infections.
- Generate reports informing bacterial resistance patterns to help doctors make better patient treatment decisions.
What do we hope to achieve?
We hope the data we collect will help develop guidelines for patients with cirrhosis in Latin America. These guidelines will ensure that doctors use the most effective antibiotics based on real-time data from our region. This should improve patient outcomes and help prevent the spread of resistant bacteria.
Detailed description
Bacterial infections are among the most common complications in patients with cirrhosis, affecting 25-46% of those hospitalized. In two-thirds of cases, these infections are diagnosed during hospitalization, while the remainder develop during the hospital stay. The high mortality rate associated with these infections is significant, with one in four patients succumbing to the complication.
Regarding origin, 30-35% of bacterial infections in patients with cirrhosis are classified as spontaneous, with the rest being non-spontaneous. Spontaneous bacterial peritonitis is the most frequently reported infection specific to patients with cirrhosis and portal hypertension. Other spontaneous infections include spontaneous bacteremia and spontaneous bacterial empyema.
A significant factor influencing patient outcomes in bacterial infections is the rapid initiation of appropriate empirical antibiotic therapy. It is generally recommended that empirical treatment covers 80% of expected bacteria in stable patients and 90% in critically ill patients. However, this goal is increasingly challenging due to shifting epidemiology, with a rise in Gram-positive organisms and a growing incidence of multidrug resistance. Recent studies have shown that 34% of infections in patients with cirrhosis are caused by multidrug-resistant microorganisms, which are linked to poorer outcomes, complicating patient management, and increasing healthcare costs.
Although guidelines for empirical antibiotic treatment exist in other regions, none have been developed for Latin America. As a result, clinicians often rely on recommendations from the United States or Europe, which may not accurately reflect the epidemiology in this region.
GENERAL OBJECTIVES
- To establish and sustain a surveillance system to monitor the antibiotic susceptibility patterns of microorganisms responsible for infections in patients with cirrhosis.
- To produce periodic reports on evolving resistance patterns of microorganisms involved in infections in patients with cirrhosis.
EXPECTED OUTCOMES
This project aligns with global strategies to address the rise in infections caused by multidrug-resistant microorganisms. By applying a research methodology based on international standards, the study aims to ensure the collection of high-quality data that can lead to actionable outcomes.
Our research team initiated this project in 2020 to create a continuous surveillance program for bacterial infections in cirrhosis patients within our region. The goal is to collect and share real-time data on antibiotic susceptibility patterns.
We expect to generate results that will enable the production of detailed reports on the susceptibility patterns of bacterial infections in patients with cirrhosis at different levels. This will provide the necessary information to develop region-specific guidelines for the appropriate use of empirical antibiotics in this population. Additionally, periodic updates will reflect ongoing epidemiological changes.
---
This structure improves the flow and maintains a scientific tone. Let me know if further revisions are needed!
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients in Latin American countries
Key inclusion criteria (3 listed)
- Episodes of culture-confirmed bacterial infections
- Patients diagnosed with cirrhosis
- Infections diagnosed either at the time of hospital admission or during hospitalization
Key exclusion criteria (2 listed)
- History of solid organ or hematopoietic stem cell transplantation
- Declined to participate in the study
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
Proportion of multidrug-resistant organisms
Time frame: 1 week
Estimated by using the total number of bacterial infection episodes involving at least one multidrug-resistant organism as the numerator and the total number of bacterial infection episodes as the denominator.
Proportion of extensively drug-resistant microorganisms
Time frame: 1 week
Estimated by using the total number of bacterial infection episodes involving at least one extensively drug-resistant microorganism as the numerator and the total number of bacterial infection episodes as the denominator.
Proportion of pan drug-resistant microorganisms
Time frame: 1 week
Estimated by using the total number of bacterial infection episodes involving at least one pan drug-resistant microorganism as the numerator and the total number of bacterial infection episodes as the denominator.
20 secondary outcomes
Proportion of episodes on infection susceptible to quinolones
Time frame: 1 week
Proportion of episodes of infection susceptible to nitrofurantoin
Time frame: 1 week
Proportion of episodes of infection susceptible to Trimethoprim-Sulfamethoxazole
Time frame: 1 week
Proportion of episodes of infection susceptible to ceftriaxone
Time frame: 1 week
Proportion of episodes of infection susceptible to ceftazidime
Time frame: 1 week
Proportion of episodes of infection susceptible to cefepime
Time frame: 1 week
Proportion of episodes of infection susceptible to aminoglycosides
Time frame: 1 week
Proportion of episodes of infection susceptible to piperacillin-tazobactam
Time frame: 1 week
Proportion of episodes of infection susceptible to ertapenem
Time frame: 1 week
Proportion of episodes of infection susceptible to meropenem/imipenem
Time frame: 1 week
Proportion of episodes of infection susceptible to colistin:
Time frame: 1 week
Proportion of episodes of infection susceptible to ceftazidime-avibactam
Time frame: 1 week
Proportion of episodes of infection susceptible to ceftolozane-tazobactam
Time frame: 1 week
Proportion of episodes of infection susceptible to piperacillin-tazobactam plus vancomycin
Time frame: 1 week
Proportion of episodes of infection susceptible to carbapenem plus vancomycin
Time frame: 1 week
Proportion of episodes of infection susceptible to carbapenem plus linezolid
Time frame: 1 week
Proportion of episodes of infection susceptible to carbapenem + linezolid
Time frame: 1 week
Proportion of episodes of infection susceptible to aminoglycoside + colistin
Time frame: 1 week
Proportion of episodes of infection susceptible to ceftazidime-avibactam + aztreonam
Time frame: 1 week
Proportion of episodes of infection susceptible to ceftazidime-avibactam + vancomycin
Time frame: 1 week
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 10 Oct 2024.
- Individual participant dataSharing planned: Yes. I am willing to share individual participant data based on the proposal, the project's relevance and importance, and ensuring data security
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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.
Sebastián M Marciano, Principal Investigator. contact
Gonzalo Gomez Perdiguero, Registry coordinator contact
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 Cirrhosis and Bacterial Infections, 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 2 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: looking for participants now, as of the sponsor's last update on 10 Oct 2024. 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 Sebastián M Marciano, Principal Investigator. (54 11 49590200 ext. 5370, sebastian.marciano@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of multidrug-resistant organisms (time frame: 1 week). 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 10 Oct 2024.