Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,160
Countries
1
Sites
22
surgical antibiotic prophylaxis
To demonstrate the non-inferiority of linezolid versus vancomycin as surgical antibiotic prophylaxis for all types of surgery in term of SSIs prevention at day-30 after surgery.
Key facts
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 30 Sep 2024 → ongoing
- Decision date (initial)
- 2023-08-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To demonstrate the non-inferiority of linezolid versus vancomycin as surgical antibiotic prophylaxis for all types of surgery in term of SSIs prevention at day-30 after surgery.
Secondary objectives 9
- To compare rates of SSI at day-90 and day-365 (non-inferiority) between the 2 groups
- To compare compliance to treatment (superiority) in the 2 groups
- To compare delays in surgery onset (superiority) in the 2 groups
- To compare hospital lenght of stay (superiority) in the 2 groups
- To compare in-hospital mortality rates (superiority) in the 2 groups
- To compare the incidence and type of micro-organisms causing the SSI (superiority) in the 2 groups
- To compare health economic analysis in the 2 groups
- To compare the quality of life in the 2 groups
- To compare patient satisfaction (superiority) in the 2 groups
Conditions and MedDRA coding
surgical antibiotic prophylaxis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- • Adult (≥18 years) patients undergoing any elective surgery for which vancomycin is recommended in the guidelines as an alternative to beta-lactams, from different specialties including: neurological, cardiac, orthopedic, vascular, urology, ENT, maxillo-facial or digestive . It is possible to include patients undergoing a re-intervention, if it is not due to a suspected or proven infection.
- • Known allergy to beta-lactams AND/OR suspected or proven MRSA colonization. Proven MRSA colonization is defined as a positive patient sample within 3 months prior to surgery. Suspected MRSA colonization is defined when the patient has received antibiotic treatment within 3 months prior to surgery or is undergoing re-intervention more than 5 days after the first surgery.
- • Signed informed consent
- • Patient affiliated to a social security system or equivalent.
Exclusion criteria 9
- • Surgery for suspected or proven SSI according to international definitions
- • Obesity defined by a body mass index (BMI) >35 kg/m2 or a body weight >100 kg
- • Chronic kidney disease defined as glomerular filtration rate (GFR) <60 ml/min per 1.73 m2
- • Known allergy to linezolid or vancomycin or one of the excipients in their respective composition
- • Patient with a history of hematologic malignancy or with ongoing hematologic malignancy
- • Declared pregnancy or breastfeeding
- • Patient under legal protection regime for adults
- • Patient already enrolled in LOVip study for a previous surgery
- • Patient with limited French proficiency
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary objective of this study is to show the non-inferiority in terms of rate of d30 post-surgery SSIs in patients receiving linezolid 1200 mg as surgical antibiotic prophylaxis compared with patients receiving vancomycin 30 mg/kg.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Linezolid Kabi 2 mg/ml solution for infusion
PRD5105836 · Product
- Active substance
- Linezolid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- 20170221
- MA holder
- FRESENIUS KABI BULGARIA EOOD
- MA country
- Bulgaria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 13
VANCOMYCINE VIATRIS 125 mg, poudre pour solution à diluer pour perfusion
PRD9502960 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- NL 20620
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE SANDOZ 500 mg, poudre pour solution à diluer pour perfusion ou pour solution buvable
PRD6971918 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 34009 556 527 3 1
- MA holder
- SANDOZ
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05076MIG · Substance
- Active substance
- Vancomycin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE SANDOZ 1 g, poudre pour solution à diluer pour perfusion
PRD6971278 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 34009 559 330 6 9
- MA holder
- SANDOZ
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE HIKMA 1000 mg, Poudre pour solution à diluer pour perfusion
PRD6561339 · Product
- Active substance
- Vancomycin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 34009 585 364 1 0
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE SANDOZ 125 mg, poudre pour solution à diluer pour perfusion
PRD6971275 · Product
- Active substance
- Vancomycin Hydrochloride
- Substance synonyms
- VANCOMYCIN HCL
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 34009 559 334 1 0
- MA holder
- SANDOZ
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE HIKMA 500 mg, Poudre pour solution à diluer pour perfusion
PRD6561337 · Product
- Active substance
- Vancomycin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 34009 585 366 4 9
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE VIATRIS 1000 mg, poudre pour solution à diluer pour perfusion
PRD9502963 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- NL22242
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE VIATRIS 250 mg, poudre pour solution à diluer pour perfusion
PRD9502961 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- NL 20621
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE VIATRIS 500 mg, poudre pour solution à diluer pour perfusion ou pour solution buvable
PRD9502962 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/Kg milligram(s)/kilogram
- Max total dose
- 30 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- NL17209
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vancomycine MIP 1000 mg, poudre pour solution pour perfusion
PRD1757726 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- NL 39083, CIS : 6 500 547 9
- MA holder
- MIP PHARMA GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vancomycine MIP 500 mg, poudre pour solution pour perfusion
PRD1757904 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- NL 39082, CIS : 6 862 482 1
- MA holder
- MIP PHARMA GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
VANCOMYCINE SANDOZ 250 mg, poudre pour solution à diluer pour perfusion
PRD6971894 · Product
- Active substance
- Vancomycin Hydrochloride
- Substance synonyms
- VANCOMYCIN HCL
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 34009 566 132 1 2
- MA holder
- SANDOZ
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Marseille
- Sponsor organisation
- Assistance Publique Hopitaux De Marseille
- Address
- 80 Rue Brochier
- City
- Marseille
- Postcode
- 13005
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Marseille
- Contact name
- coordinating investigator
Public contact point
- Organisation
- Assistance Publique Hopitaux De Marseille
- Contact name
- coordinating investigator
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 1,160 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
anesthésie-réanimation, 2 Rue De La Miletrie, 86000, Poitiers
Hopital De La Croix Rousse
anesthésie-réanimation, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Assistance Publique Hopitaux De Paris
anesthésie-réanimation, 2 Rue Ambroise Pare, 75010, Paris
Hopital Prive Jean Mermoz
anesthésie-réanimation, 55 Avenue Jean Mermoz, 69008, Lyon
Assistance Publique Hopitaux De Paris
anesthésie-réanimation, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Clinique Generale
anesthésie-réanimation, 4 Chemin De La Tour La Reine, 74000, Annecy
CHRU De Nancy
anesthésie-réanimation, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Assistance Publique Hopitaux De Paris
anesthésie-réanimation, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Marseille
anesthésie-réanimation, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
anesthésie-réanimation, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Universitaire Grenoble Alpes
anesthésie-réanimation, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Toulouse
anesthésie-réanimation, Place Du Docteur Joseph Baylac, 31000, Toulouse
Centre Hospitalier Universitaire De Nimes
anesthésie-réanimation, Place Du Professeur Robert Debre, 30900, Nimes
Centre Hospitalier Universitaire De Bordeaux
anesthésie-réanimation, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Montpellier
anesthésie-réanimation, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Assistance Publique Hopitaux De Marseille
anesthésie-réanimation, 147 Boulevard Baille, 13005, Marseille
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
anesthésie-réanimation, Avenue Des Tamaris, 13100, Aix-En-Provence
Assistance Publique Hopitaux De Marseille
anesthésie-réanimation, 265 Chemin Des Bourrely, 13015, Marseille
CHU Gabriel-Montpied
anesthésie-réanimation, 58 Rue Montalembert, 63000, Clermont Ferrand
Les Hopitaux Universitaires De Strasbourg
anesthésie-réanimation, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Hospices Civils De Lyon
anesthésie-réanimation, 3 Quai Des Celestins, Bp 2251, Lyon Cedex 02
C.H.U. de Montpellier - Hopital Saint Eloi
anesthésie réanimation, 80 Av Augustin Fliche, 34295, Montpellier Cedex 5
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 | 2024-09-30 | 2024-11-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2023-504986-22-00_protocole_LOVIP | 4 |
| Protocol (for publication) | D1_Protocol_2023-504986-22-00 | 6.2 |
| Protocol (for publication) | D1_Protocole_2023-504986-22-00_TC | 6.2 |
| Protocol (for publication) | D1_Protocole_2023-504986-22-00-SoC | 1 |
| Protocol (for publication) | D1_Protocole_MS4_2023-504986-22-00 | 5 |
| Recruitment arrangements (for publication) | 2023-504986-22-00_Recruitment arrangements_LOVIP | 1 |
| Subject information and informed consent form (for publication) | 2023-504986-22-00_Formulaire consentement patient_LOVIP | 3 |
| Subject information and informed consent form (for publication) | 2023-504986-22-00_Note information patient_LOVIP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_Adult | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_Adult_TC | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_LINEZOLIDE KABI | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP LINEZOLIDE KABI _LOVIP | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP VANCOMYCINE SANDOZ 1g_LOVIP | 3 |
| Synopsis of the protocol (for publication) | 2023-504986-22-00_synopsis_LOVIP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_2023-504986-22-00 | 5 |
| Synopsis of the protocol (for publication) | D1_Protocole_Synopsis_2023-504986-22-00_TC | 5 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-22 | France | Acceptable 2023-08-17
|
2023-08-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-04 | France | Acceptable | 2023-09-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-02 | France | Acceptable 2023-11-16
|
2023-11-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-22 | France | Acceptable 2024-03-26
|
2024-04-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-24 | France | Acceptable 2025-05-16
|
2025-05-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-19 | France | Acceptable 2025-12-12
|
2025-12-12 |