Actively Recruiting
Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis
Led by Eva Bonfill · Updated on 2024-09-27
198
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating antibiotic treatment strategies in patients with cirrhosis who have bacterial infections. This randomized controlled trial compares standard antibiotic approaches against treatments guided by colonization and epidemiological surveillance. The study targets adults with decompensated cirrhosis to assess if surveillance-based regimens can influence outcomes related to antibiotic resistance and infection management. Participants are randomly assigned to one of two groups. The control group receives antibiotics following the local guidelines of the Hospital Clinic de Barcelona, while the experimental group receives treatment based on these guidelines but adjusted according to colonization and epidemiological surveillance results. Treatments are administered according to hospital protocols, and the trial is conducted without masking. During the study, researchers monitor participants for up to 28 days, assessing the development of antibiotic resistance, colonization and infection with multidrug-resistant organisms, and infection resolution. They also evaluate liver function scores, length of hospital and ICU stays, life support needs, rehospitalization rates, antibiotic consumption, health costs, and safety events related to antibiotics. This comprehensive monitoring aims to understand the impact of surveillance-guided antibiotic regimens on patient outcomes and healthcare resource use.
CONDITIONS
Brief Title
Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cirrhotic patients with acute decompensation aged 18 years or older
- Proven or suspected bacterial infection requiring antibiotic therapy
- Signed informed consent by the patient or their legal representative or close relatives
You will not qualify if you...
- Bacterial infection lasting for more than 48 hours
- Infection in a critically ill cirrhotic patient admitted to ICU
- Evidence of current locally advanced or metastatic malignancy (except hepatocellular carcinoma within Milan criteria and non-melanocytic skin cancer)
- Pregnant and/or breast-feeding women
- Patients unable to provide prior informed consent without a legal surrogate and unlikely to regain consciousness or consent ability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days or until hospital discharge
Participants receive antibiotic treatment according to either conventional strategies or regimens guided by epidemiological surveillance.
Visits during hospitalization as per treatment and monitoring needs
Duration - Up to 28 days after treatment start
Participants are monitored for antibiotic resistance development, infection outcomes, and survival up to 28 days after treatment initiation.
Follow-up visits up to day 28 including hospital discharge assessments
Trial Site Locations
Total: 1 location
1
Eva Bonfill
Barcelona, Spain, 08036
Actively Recruiting
Research Team
E
Eva Bonfill
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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