Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
326
Countries
1
Sites
27
Patients with preoperative biliary stent treated by pancreaticoduodenectomy
To compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)
Key facts
- Sponsor
- Centre Hospitalier Universitaire Rouen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 20 May 2026 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515181-14-00
- EudraCT number
- 2021-006991-18
- ClinicalTrials.gov
- NCT06123169
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)
Secondary objectives 5
- Evaluation of the overall morbidity associated with the different treatment modes by recording surgical complications
- Evaluation of antibiotic resistance profiles and their impact on post-operative complications
- Assessment of the pathogenicity of bacteriological and fungal co-contamination
- Evaluation of the impact of complications after bile drainage and neoadjuvant treatment on the bacteriological and fungal profile of biliculture
- Cost effectiveness analysis
Conditions and MedDRA coding
Patients with preoperative biliary stent treated by pancreaticoduodenectomy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10073866 | Tumor of hepatopancreatic ampulla | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Planned pancreaticoduodenectomy for periampullary neoplasms
- Endoscopic or radiological pre-operative biliary drainage
- Age ≥ 18 years old
- Patient able to comply with the study protocol, in the investigator’s judgment
- Patient affiliated with, or beneficiary of a social security (national health insurance) category
- Person of full age having read and understood the information letter and signed the consent form
- Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) with hightly effective contraception (Cf. CTFG) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) since 1 month and during the duration of the study and a negative blood pregnancy test by beta-HCG at inclusion.
- Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Exclusion criteria 11
- Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection in accordance with its SmPC
- Simultaneous participation in another interventional research with the same primary endpoint.
- Patients allergic to beta-lactam antibiotics
- Others pancreatic resection
- Absence of preoperative biliary drainage
- Surgical or anaesthesiological contra-indications: • non-controlled congestive heart failure – non-treated angina – recent myocardial infarction (in the previous year) – non-controlled AHT (SBP >160 mm or DBP > 100 mm, despite optimal drug treatment), long QT • major non-controlled infection • severe liver failure
- Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
- Any significant disease, which, in the investigator’s opinion, would exclude the patient from the study
- Pregnant or parturient or breastfeeding woman or absence of contraceptionn
- Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision
- Severe renal failure
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the presence of organ/space SSI determined according to the Centers for Disease Control and Prevention’s national nosocomial infections surveillance system. Organ/space SSIs included postoperative pancreatic fistula (POPF) and bile leakage, with positive culture results.
Secondary endpoints 6
- Infectious complications at post-operative day 90 Overall postsurgical morbidity, graded according to the Dindo/Clavien classification and CCI score at post operative day 90 Specific morbidity due to pancreatic fistula, graded according to the International Study Group of Pancreatic Fistula (ISGPF) criteria Readmission rates at post-operative day 90 Duration of hospitalization
- Correlation between post-operative bacteriological samples and intraoperative bile samples
- Bacteriological resistance profiles
- Incidence of fungal contamination
- Correlation between bacteriological and fungal contaminations
- Incremental cost per infectious complications avoided
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PIPERACILLINE/TAZOBACTAM KABI 4 g/ 500 mg, poudre pour solution pour perfusion.
PRD3364938 · Product
- Active substance
- Piperacillin Sodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 12 g gram(s)
- Max total dose
- 72 g gram(s)
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 34009 392 149 1 7
- MA holder
- FRESENIUS KABI FRANCE S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Rouen
- Sponsor organisation
- Centre Hospitalier Universitaire Rouen
- Address
- 1 Rue De Germont, Bp 96031 Bp 96031
- City
- Rouen Cedex
- Postcode
- 76031
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Rouen
- Contact name
- David MALLET
Public contact point
- Organisation
- Centre Hospitalier Universitaire Rouen
- Contact name
- David MALLET
Locations
1 EU/EEA country · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 326 | 27 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Chirurgie Digestive et Oncologique, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Centre Hospitalier De Versailles
Chirurgie digestive et oncologique, 177 Rue De Versailles, Le Chesnay, Le Chesnay Rocquencourt
Centre Hospitalier Universitaire De Toulouse
Chirurgie Digestive, 2 Rue Viguerie, Tsa 80035, Toulouse Cedex 9
Institut Paoli Calmettes
Chirurgie oncologique, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Nantes
Chirurgie Digestive et Endocrine, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Assistance Publique Hopitaux De Paris
Chirurgie Digestive Hépatobiliaire et Endocrinienne, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Bretagne Atlantique
Réanimation, 20 Boulevard General Maurice Guillaudot, 56000, Vannes
Hopitaux Universitaires Pitie Salpetriere
Chirurgie Digestive Hépatobiliaire et Endocrinienne, 47 To 83 Boulevard De L Hopital, 75013, Paris
Hopital Paul Brousse
Chirurgie Viscérale et Digestive, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Centre Hospitalier Regional Universitaire De Tours
Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, 2 Boulevard Tonnelle, 37000, Tours
Hôpital Européen Marseille
chirurgie digestive, 6 Rue Désirée Clary, 13003, Marseille
Centre Hospitalier Universitaire De Lille
Chirurgie Digestive et transplantations, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
University Hospital Of Clermont-Ferrand
Cancérologie Chirurgie Générale, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
CHRU De Nancy
Chirurgie viscérale et digestive, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Hopital Beaujon
Chirurgie hépato-pancréato-biliaire et transplantations hepatiques, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Rennes
Chirurgie Viscérale et Digestive, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire Amiens Picardie
Chirurgie Digestive, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
CHU Besancon
Chirurgie Viscérale et Digestive, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire Rouen
Chirurgie digestive, 1 Rue De Germont, Bp 96031, Rouen Cedex
Institut Gustave Roussy
Chirurgie Générale, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Lille
Chirurgie Digestive et oncologique, 1 Place De Verdun, 59000, Lille
Hospices Civils De Lyon
Chirurgie Viscérale et Digestive, 5 Place D Arsonval, 69437, Lyon Cedex 03
Hopital Prive Jean Mermoz
Chirurgie générale, 55 Avenue Jean Mermoz, 69008, Lyon
Les Hopitaux Universitaires De Strasbourg
Chirurgie Digestive, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire D'Angers
Chirurgie digestive, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Montpellier
Chirurgie Digestive, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Assistance Publique Hopitaux De Paris
Chirurgie Digestive et Oncologique, 20 Rue Leblanc, 75908, Paris Cedex 15
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-05-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | B1_Description modifications_2024-515181-14-00 | 1.3 |
| Protocol (for publication) | D1_Protocol_2024-515181-14-00_Clean | 4.2 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_2024-515181-14-00 | 1 |
| Subject information and informed consent form (for publication) | L1_NICE_2024-515181-14-00_Clean | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC PIPERACILLINE_TAZOBACTAM KABI | NA |
| Synopsis of the protocol (for publication) | D1_RESUME Protocole_2024-515181-14-00_Clean | 4.2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | France | Acceptable 2024-09-12
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-27 | France | Acceptable with conditions 2025-04-22
|
2025-04-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-02 | France | Acceptable 2026-05-06
|
2026-05-07 |