Decompensated CirrhosisPhase 4SURVICNCT05783661
Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
A Phase 4 study testing Conventional antibiotic strategies and Regimens guided by epidemiological surveillance in people with Decompensated Cirrhosis and Bacterial Infections, run by Eva Bonfill at 1 site in Spain.
Trial summary
Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis, Bacterial Infections
- What is being tested?
- Conventional antibiotic strategies and Regimens guided by epidemiological surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSpain
- Study dates
- 11 Dec 2023to Mar 2027
- Phase
- Phase 4
- 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
Who may be able to join
- Cirrhotic patients with acute decompensation aged ≥18 years.
- Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).
- Signed informed consent or consent given by their legal representatives or close relatives.
Who cannot join
- Bacterial infection lasting for > 48 hours.
- Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.
- MDR colonization or infection in the last month.
- Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
- Pregnant and/or breast-feeding woman.
- Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis
Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.
- Conditions
- Decompensated Cirrhosis, Bacterial Infections
- Being tested
- Conventional antibiotic strategies, Regimens guided by epidemiological surveillance
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional antibiotic strategiesOther
Treatment according to the local guidelines of the Hospital Clinic de Barcelona.
Regimens guided by epidemiological surveillanceOther
Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Conventional antibiotic strategies | Active comparator | The control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona. Receives: Other: Conventional antibiotic strategies |
| Regimens guided by epidemiological surveillance | Experimental | The experimental group will receive treatment to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance. Receives: Other: Regimens guided by epidemiological surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
Measured by the appearance of new colonizations and/or infections by MDROs.
Measured: 28 days
Secondary outcomes (24)
Probability of antibiotic resistance development during hospitalization in both treatment arms.
Measured by the appearance of new colonizations and/or infections by MDROs.
Measured: During hospitalization (until discharge), assessed up to day 28.
Rate of antibiotic resistance development during hospitalization in both treatment arms.
Measured by the appearance of new colonizations and/or infections by MDROs.
Measured: During hospitalization (until discharge), assessed up to day 28.
Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.
Measured by the appearance of new colonications by MDROs.
Measured: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.
Measured by the appearance of new colonications by MDROs.
Measured: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Rate of MDRO infection during hospitalization and at 28 days in both treatment arms.
Measured by the appearance of new infections by MDROs.
Measured: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Probability of MDRO infection during hospitalization and at 28 days in both treatment arms.
Measured by the appearance of new infections by MDROs.
Measured: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Infection resolution rate with initial and final strategies in both treatment arms.
Measured by the number of infections resolution with initial strategies or final strategies.
Measured: Through study completion, an average of 28 days
Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.
Measured by the result of ACLF score. Minimum ACLF score: 6 points. Maximum ACLF score: 18 points. Higher scores means a worse result.
Measured: Through study completion, an average of 28 days
Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.
Measured by the result of MELD score. Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores means a worse result.
Measured: Through study completion, an average of 28 days
Evolution of score Child-Pugh in both treatment arms.
Measured by the result of Child -Pugh score. Minimum Child-Pugh score: 5 points. Maximum Child-Pugh score: 15 points. Higher scores means a worse result.
Measured: Through study completion, an average of 28 days
Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.
Measured by the result of CLIF-OF score. Minimum CLIF-OF score: 6 points. Maximum CLIF-OF score: 18 points. Higher scores means a worse result.
Measured: Through study completion, an average of 28 days
Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.
Measured by the result of CLIF-C AD score.
Minimum CLIF-C AD score: 6 points. Maximum CLIF-C AD score: 18 points. Higher scores means a worse result.
Measured: Through study completion, an average of 28 days
Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.
Measured by the result of CLIF-C ACLF score. Minimum CLIF-C ACLF score: 6 points. Maximum CLIF-C ACLF score: 18 points. Higher scores means a worse result.
Measured: Through study completion, an average of 28 days
Days of admission to the ICU if needed.
Measured by the days of admission to the ICU.
Measured: Through study completion, an average of 28 days
Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.
Measured by the days of life support.
Measured: Through study completion, an average of 28 days
Days of hospital stay
Measured by the days of hospital stay.
Measured: Through study completion, an average of 28 days
Number of rehospitalizations.
Measured by the number of rehospitalizations.
Measured: Through study completion, an average of 28 days
Antibiotics consumption
Measured by the days of antibiotics consumption.
Measured: Through study completion, an average of 28 days
Antibiotics consumption
Measured by dose of antibiotics.
Measured: Through study completion, an average of 28 days.
Antibiotics consumption
Measured by type of antibiotics.
Measured: Through study completion, an average of 28 days
Health costs
Measured by the cost of antibiotic, cost of hospital/ICU stay and of organ support(s).
Measured: Through study completion, an average of 28 days
Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
Measured by the number of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
Measured: Through study completion, an average of 28 days
Hospital survival
Number of survival participants
Measured: During hospitalization (until discharge), assessed up to day 28.
28-day survival
Number of survival participants
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start11 Dec 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will recieve: 1. Antibiotic regimens guided by colonization/epidemiological surveillance. 2. Conventional antibiotic regimens.
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eva Bonfill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eva Bonfill, Institut d'Investigacions Biomèdiques August Pi i Sunyer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783661
- Sponsor's protocol ID
- 2022-001858-33
- Acronym
- SURVIC
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT05783661
- Acronym / sponsor ID
- SURVIC / 2022-001858-33
- Conditions
- Decompensated Cirrhosis, Bacterial Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Eva BonfillUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Mar 2023 (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.
Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will recieve: 1. Antibiotic regimens guided by colonization/epidemiological surveillance. 2. Conventional antibiotic regimens.
| Arm | Type | Receives |
|---|---|---|
| Conventional antibiotic strategies | Active comparator | Other: Conventional antibiotic strategiesThe control group will receive treatment according to the local guidelines of the Hospital Clinic de Barcelona. |
| Regimens guided by epidemiological surveillance | Experimental | Other: Regimens guided by epidemiological surveillanceThe experimental group will receive treatment to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cirrhotic patients with acute decompensation aged ≥18 years.
- Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).
- Signed informed consent or consent given by their legal representatives or close relatives.
Key exclusion criteria (6 listed)
- Bacterial infection lasting for > 48 hours.
- Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.
- MDR colonization or infection in the last month.
- Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
- Pregnant and/or breast-feeding woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional antibiotic strategiesTreatment according to the local guidelines of the Hospital Clinic de Barcelona. | Other | Conventional antibiotic strategies |
| Regimens guided by epidemiological surveillanceTreatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance. | Other | Regimens guided by epidemiological surveillance |
Primary outcome
Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
Time frame: 28 days
Measured by the appearance of new colonizations and/or infections by MDROs.
24 secondary outcomes
Probability of antibiotic resistance development during hospitalization in both treatment arms.
Time frame: During hospitalization (until discharge), assessed up to day 28.
Rate of antibiotic resistance development during hospitalization in both treatment arms.
Time frame: During hospitalization (until discharge), assessed up to day 28.
Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Rate of MDRO infection during hospitalization and at 28 days in both treatment arms.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Probability of MDRO infection during hospitalization and at 28 days in both treatment arms.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Infection resolution rate with initial and final strategies in both treatment arms.
Time frame: Through study completion, an average of 28 days
Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.
Time frame: Through study completion, an average of 28 days
Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.
Time frame: Through study completion, an average of 28 days
Evolution of score Child-Pugh in both treatment arms.
Time frame: Through study completion, an average of 28 days
Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.
Time frame: Through study completion, an average of 28 days
Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.
Time frame: Through study completion, an average of 28 days
Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.
Time frame: Through study completion, an average of 28 days
Days of admission to the ICU if needed.
Time frame: Through study completion, an average of 28 days
Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.
Time frame: Through study completion, an average of 28 days
Days of hospital stay
Time frame: Through study completion, an average of 28 days
Number of rehospitalizations.
Time frame: Through study completion, an average of 28 days
Antibiotics consumption
Time frame: Through study completion, an average of 28 days
Antibiotics consumption
Time frame: Through study completion, an average of 28 days.
Antibiotics consumption
Time frame: Through study completion, an average of 28 days
Health costs
Time frame: Through study completion, an average of 28 days
Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
Time frame: Through study completion, an average of 28 days
Hospital survival
Time frame: During hospitalization (until discharge), assessed up to day 28.
28-day survival
Time frame: 28 days
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 7 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional antibiotic strategies and Regimens guided by epidemiological surveillance in people with Decompensated Cirrhosis and Bacterial Infections, run by Eva Bonfill at 1 site in Spain.
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 6 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 7 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eva Bonfill (+34 932275400 ext. 4198, bonfill@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days. (time frame: 28 days). 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 7 Jul 2026.