Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
456
Countries
1
Sites
17
Pyogenic liver abscess
Demonstrate that an antibiotic therapy (ATB) of 3 weeks after drainage of pyogenic liver abscess is non-inferior in terms of treatment failure at week 12 after drainage, compared to a 6 weeks ATB.
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-10-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Health Ministry
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
Demonstrate that an antibiotic therapy (ATB) of 3 weeks after drainage of pyogenic liver abscess is non-inferior in terms of treatment failure at week 12 after drainage, compared to a 6 weeks ATB.
Secondary objectives 10
- 1- Demonstrate that 3 weeks ATB is non-inferior to 6 weeks in terms of mortality of any cause.
- 2- Demonstrate the superiority of 3 weeks ATB versus 6 weeks in terms of emergence of digestive colonization by MDRB.
- 3- Compare the proportion of patients with a treatment failure at the end of the ATB assigned by the randomization.
- 4- Compare the proportion of patients with complete regression of liver abscess(es) images at weeks 3, 6, and 12 after drainage, overall, and according to the ATB duration,
- 5- Compare the time to hospital discharge, overall, and according to the ATB duration, the abscess’ and patient’s characteristics.
- 6- Describe the intercurring events between week 12 and month 6 in each group (e.g. relapse of index infection, new liver abscess(es), death from any cause,…)
- 7- Describe the clinical, anatomical, and microbiological characteristics of the pyogenic liver abscess(es).
- 8- Describe the characteristics and modalities of the antibiotic therapy administered to the participant (molecules, modalities, duration).
- 9- Identify risk factors of failure of treatment, overall, and according to ATB duration.
- 10- Evaluate the safety of each treatment protocol
Conditions and MedDRA coding
Pyogenic liver abscess
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10068844 | Pyogenic liver abscess | 10021881 |
| 20.0 | SOC | 10021881 | Infections and infestations | 1 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | TIME TO LIA Randomized, open-label, non-inferiority trial of 3 vs 6 weeks of ATB for the treatment of pyogenic liver abscess
|
Randomised Controlled | None | Bras court: 3 semaines de TT ATB Bras standard: 6 semaines de TT ATB |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Age ≥ 18 years old
- - Intra-hepatic abscess assessed by radiological evaluation (CT)
- - Bacterial confirmation by culture of pus extracted from liver abscess
- - Success of drainage (percutaneous drainage or aspiration by punction) defined by regression > 50 % of the size of the abscess on liver ultrasonography or CT at day 10 after +/- 2 days PLA drainage compared to the abscess size on CT performed before drainage.
Exclusion criteria 12
- - Non pyogenic bacterial aetiology of PLA: fungal, parasitic, mycobacterial, or absence of documentation
- - Extra-hepatic abscess or infection in another site for which the duration of ATB would be longer than 3 weeks.
- - PLA occurring after liver transplantation or in a liver recipient patient.
- - Ischemic cholangitis as aetiology of PLA
- - Associated other(s) liver abcess(es) > 3 cm with no drainage possible
- - Contraindications to investigational medicinal products
- - Pregnant / breastfeeding women
- - Non-affiliation to a social security regimen or CMU
- - Patient refusal to participate or no possibility to give consent
- - Patient under guardianship or trusteeship
- - Subject already involved in another interventional clinical research evaluating a medicinal product
- - Subject already involved in another interventional clinical research evaluating an interventional procedure for PLA treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients with a treatment failure between the end of treatment and week 12 after the drainage of the abscess(es).
Secondary endpoints 11
- 1. Time to death of any cause
- 2. Proportion of patients with digestive colonization of MDRB at inclusion and at week 12 after drainage, assessed by rectal swabs.
- 3. Proportion of participants with treatment failure at the end of the ATB assigned by randomization.
- 4. Proportion of participants with complete regression of liver abscess(es) images at week 3, week 6, and week 12 after drainage.
- 5. Time to hospital discharge
- 6. Intercurring events between week 12 and month 6 in each group (e.g. relapse of index infection, new liver abscess(es), death from any cause)
- 7. Clinical, anatomical, and microbiological characteristics of the PLA. Clinical, biological and treatment characteristics of the patients.
- 8. Characteristics and modalities of the antibiotic therapy administered to the participant (molecules, modalities, duration).
- 9. Proportion of patients with an extended ATB longer than the duration assigned by the randomisation.
- 10. Proportion of patients with an appropriate ATB related to the bacterial documentation (intravenous and oral).
- 11. Incidence of adverse events and serious adverse events.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
SCP32518756 · ATC
- Active substance
- Meropenem
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DH52 — MEROPENEM AND VABORBACTAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP108760575 · ATC
- Active substance
- Daptomycin
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XX09 — DAPTOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP108746144 · ATC
- Active substance
- Amikacin Sulfate
- Substance synonyms
- AMIKACIN SULPHATE
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01GB06 — AMIKACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP1935197 · ATC
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XX11 — TEDIZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
J01C · Product
- Pharmaceutical form
- -
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01C — BETA-LACTAM ANTIBACTERIALS, PENICILLINS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13237974 · ATC
- Active substance
- Ceftazidime
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DD52 — CEFTAZIDIME AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13835914 · ATC
- Active substance
- Linezolid
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
J01MA · Product
- Pharmaceutical form
- PHF00082MIG
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA — FLUOROQUINOLONES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1153368 · ATC
- Active substance
- Metronidazole
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XD01 — METRONIDAZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
J01X · Product
- Pharmaceutical form
- -
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01X — OTHER ANTIBACTERIALS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP40975146 · ATC
- Active substance
- Cilastatin
- Substance synonyms
- LSALT peptide
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DH56 — IMIPENEM, CILASTATIN AND RELEBACTAM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
J01D · Product
- Pharmaceutical form
- -
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01D — OTHER BETA-LACTAM ANTIBACTERIALS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP105620723 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XB01 — COLISTIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1166649 · ATC
- Active substance
- Bromhexine Hydrochloride
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Geoffrey ROSSI
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Geoffrey ROSSI
Locations
1 EU/EEA country · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 456 | 17 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire D'Angers
Maladies infectieuses et tropicales, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional Universitaire De Tours
Maladies infectieuses, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Hospital Foch
Unité transversale d'Infectiologie, 40 Rue Worth, 92150, Suresnes
Hospices Civils De Lyon
Hepato-gastro-entérologie, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Assistance Publique Hopitaux De Paris
Hepato-gastro-entérologie, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Centre Hospitalier Universitaire De Rennes
Hepato-gastro-entérologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Assistance Publique Hopitaux De Paris
Unité transversale de traitement des Infections, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Assistance Publique Hopitaux De Paris
Médecine Interne, 100 Boulevard Du General Leclerc, 92110, Clichy
Hospices Civils De Lyon
Maladies infectieuses et tropicales, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Rennes
Maladies infectieuses, 2 Rue Henri Le Guilloux, 35000, Rennes
CHU Besancon
Hepato-gastro-entérologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Maladies infectieuses, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Dijon
Maladies infectieuses, 14 Rue Paul Gaffarel, 21000, Dijon
Assistance Publique Hopitaux De Paris
Equipe mobile d'Infectiologie, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Montpellier
Hepato-gastro-entérologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Sud Francilien
Maladies infectieuses et tropicales, 40 Avenue Serge Dassault, 91106, Corbeil Essonnes Cedex
Assistance Publique Hopitaux De Paris
Maladies infectieuses, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-520940-14-00 | 1-1 |
| Protocol (for publication) | D4_Patient facing documents_carte-patient | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_majeur | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_doc-traca-ville | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AMIKACINE VIATRIS 50 mg-1 ml- solution injectable | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amoxicilline-Acide clavulanique TEVA 500 mg-62,5 mg ADULTES - comprime pellicule | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_BACTRIM FORTE - comprime secable | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_BACTRIM- solution injectable pour perfusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_COLISTIMETHATE SODIQUE AMDIPHARM 1000000 UI poudre et solvant pour solution injectable | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_DAPTOMYCINE TILLOMED 500 mg- poudre pour solution injectable-pour perfusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_FLAGYL 500 mg- comprime pellicule | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_LEVOFLOXACINE ARROW 5 mg-mL- solution pour perfusion en poche | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_LEVOFLOXACINE SANDOZ 500 mg- comprime pellicule secable | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_LINEZOLIDE KABI 2 mg-ml- solution pour perfusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_LINEZOLIDE STRAGEN 600 mg- comprime pellicule | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmpC_METRONIDAZOLE BAXTER 0 5 POUR CENT- solution injectable en poche | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Piperacilline-Tazobactam EG 4g-500mg- poudre pour solution pour perfusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Recarbrio 500 mg-500 mg-250 mg powder for solution for infusion_maj24092024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ROCEPHINE 1 g-10 mL- poudre et solvant pour solution injectable | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Sivextro 200 mg film-coated tablets | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vaborem 1 g-1 g powder for concentrate for solution for infusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_VANCOMYCINE SANDOZ 1 g- poudre pour solution a diluer pour perfusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Zavicefta 2 g-0 5 g powder for concentrate for solution for infusion | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR_2025-520940-14-00 | 1-1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-19 | France | Acceptable with conditions 2025-09-29
|
2025-10-06 |