Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
198
Countries
1
Sites
1
Hospitalized patients with decompensated cirrhosis, diagnosed with bacterial infection evolution lasting for 48 hours or less.
To evaluate the probability/rate of antibiotic resistance development at 28 days after inclusion in both groups of patients, defined based on the appearance of new colonizations and/or infections by MDROs.
Key facts
- Sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-12-19
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519974-38-00
- EudraCT number
- 2022-001858-33
- ClinicalTrials.gov
- NCT05783661
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Diagnosis
To evaluate the probability/rate of antibiotic resistance development at 28 days after inclusion in both groups of patients, defined based on the appearance of new colonizations and/or infections by MDROs.
Secondary objectives 8
- Evaluate the impact of both antibiotic strategies on: -Probability and rate of antibiotic resistance development during hospitalization. - Probability and rate of MDROs colonization during hospitalization and at 28 days. - Probability and rate of MDROs infection during hospitalization and at 28 days. - Infection resolution rate (initial and final strategies). - Evolution of severity scores: ACLF, MELD, Child-Pugh, CLIF-OF, CLIF-C AD, and CLIF-C ACLF score (inclusion, infection resolution or day 7, reinfection, hospital discharge and hospital re- admission).
- To determinate the days of admission to the ICU if needed.
- To determinate the days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.
- To determinate the days of hospital stay.
- To determinate the number of rehospitalizations.
- To determinate the antibiotics consumption (DDD) and health costs.
- To evaluate the safety of both antibiotic strategies (AE and SAE related to antibiotic therapy and SUSARS and other SAEs).
- Hospital and 28 days survival (rate and probability).
Conditions and MedDRA coding
Hospitalized patients with decompensated cirrhosis, diagnosed with bacterial infection evolution lasting for 48 hours or less.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10021804 | Infection bacterial | 10021881 |
| 20.1 | LLT | 10064704 | Decompensated cirrhosis | 10019805 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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.
Exclusion criteria 6
- Bacterial infection lasting for > 48 hours.
- Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical prac- tice.
- MDR colonization or infection in the last month.
- Evidence of current locally advanced or metastatic malignancy (pa- tients 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days (composite variable: MDRO colonization and/or infection).
Secondary endpoints 8
- Evaluate the impact of both antibiotic strategies on: - Rate and probability of developing antibiotic resistance during hospitalization. - Rate and probability of MDRO colonization during hospitalization and at 28 days. - Rate and probability of MDRO infection during hospitalization and at 28 days. - Infection resolution rate with initial and final strategies. - Evolution of scores: ACLF, MELD, Child-Pugh, CLIF-OF, CLIF- C AD, and CLIF-C ACLF score.
- Days of admission to the ICU if needed.
- Days of life support (dialysis, vasopressors, and mechanical ventila- tion) if needed.
- Days of hospital stay.
- Number of rehospitalizations.
- Antibiotics consumption (days, dose and type of antibiotics) and health costs (cost of antibiotic, cost of hospital/ICU stay and of organ support(s)).
- Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
- Hospital and 28-day survival.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Norfloxacino Sandoz 400 mg comprimidos EFG
PRD800526 · Product
- Active substance
- Norfloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 5600 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA06 — NORFLOXACIN
- Marketing authorisation
- 62622
- MA holder
- SANDOZ FARMACÉUTICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Sponsor organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Address
- Calle Rosellon 149-153
- City
- Barcelona
- Postcode
- 08036
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Dr. Javier Fernandez
Public contact point
- Organisation
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Contact name
- Dr. Javier Fernandez
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 198 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519974-38-00_redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_1_Appendix 1 Information personl data protection_SP | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and IFC_SP_adults | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Norfloxacino | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-13 | Spain | Acceptable 2024-12-19
|
2024-12-19 |