Comparing antibiotic strategies for infected patients with cirrhosis
Randomized Controlled Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis
This study tests whether using regular antibiotics or those chosen based on infection data works better for adults with cirrhosis and bacterial infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigacions Biomèdiques August Pi i Sunyer Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05783661 on ClinicalTrials.gov |
What this trial studies
This trial compares conventional antibiotic treatments with those guided by epidemiological surveillance in patients suffering from decompensated cirrhosis and bacterial infections. The study aims to determine which approach is more effective in managing infections in this vulnerable population. Patients aged 18 and older with acute decompensation and a bacterial infection will be included, while those with certain exclusions, such as critically ill patients or those with advanced malignancies, will not be eligible.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with decompensated cirrhosis and a proven or suspected bacterial infection requiring antibiotic therapy.
Not a fit: Patients with bacterial infections lasting more than 48 hours or those in critical condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective antibiotic treatment strategies for patients with cirrhosis, potentially improving their recovery and survival rates.
How similar studies have performed: While there may be studies on antibiotic strategies in similar populations, this specific comparison of conventional versus epidemiologically guided regimens is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cirrhotic patients with acute decompensation aged ≥18 years. 2. Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1). 3. Signed informed consent or consent given by their legal representatives or close relatives. Exclusion Criteria: 1. Bacterial infection lasting for \> 48 hours. 2. Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice. 3. Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included). 4. Pregnant and/or breast-feeding woman. 5. 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.
Where this trial is running
Barcelona
- Eva Bonfill — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Eva Bonfill
- Email: bonfill@recerca.clinic.cat
- Phone: +34 932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.