Randomized open-label controlled trial evaluating a single-dose intravenous Dalbavancin versus standard antibiotic therapy during catheterrelated bloodstream infections due to Staphylococcus aureus [DALICATH]

Start 23 Jun 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 34 sites · Protocol APHP220763

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 406

Countries 1

Sites 34

Catheter related bloodstream infections due to Staphylococcus aureus

To demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit).

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]
Trial duration: 23 Jun 2023 → ongoing
Decision date (initial): 2024-09-12
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: DGOS - French Ministry of Health

External identifiers

EU CT number: 2024-514952-34-00
EudraCT number: 2021-004038-12
ClinicalTrials.gov: NCT05117398

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Secondary objectives 7

Cure rate at DAY 14 and DAY 90 (EOS)
Mortality rate within 90 days of follow-up
Time to negativation of blood cultures
Patient’s quality of life
Hospitalization length of stay
Cost-utility analyses
Occurrence of any adverse event (AE and SAE), until Day 90 (EOS)

Conditions and MedDRA coding

Catheter related bloodstream infections due to Staphylococcus aureus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

Patients aged at least 18 years
First blood culture positive for S. aureus, obtained within 96 hours before randomization (the date considered is the date of the sampling, not the results)
CR-BSI, defined as: o One positive blood culture AND Local signs of infection at the catheter site OR o at least one positive blood culture obtained from the catheter and the peripheral vein, AND o A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND o Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR o One positive blood culture AND o Strong presumption of catheter-related infection according to clinical opinion
Intravascular catheter – implantable venous access device (port-a-cath and Piccline) – removed before randomization
Informed consent form date and signed by the patient

Exclusion criteria 20

Polymicrobial BSI (Bloodstream infection)
Dalbavancin resistant strain (A strain sensitive to vancomycin or methicillin (by culture or molecular method) is considered sensitive to dalbavancin)
More than 96 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization
Patient with known valvulopathy at risk of endocarditis according to the clinician, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge
Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion)
Thrombophlebitis clinical or clinically significant
Failure to remove any intravascular catheter which was present when first positive blood culture
Signs of infection associated with qSOFA score ≥ 2 at randomization
Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device
Severe liver disease (Child-Pugh C)
Severely immunocompromised patients: o Neutropenia (< 500 neutrophils/µL) at randomization; o Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period; o Solid organ transplant;
Contraindication to dalbavancin and/or glycopeptid
Life expectancy < 3 months
Active injection drug user
Pregnant or breastfeeding women
For premenopausal women: failure to use highly-effective contraceptive methods for 1 month after receiving study drug
Participation in other interventional trials ongoing on antibiotic treatment (participation in another interventional trial not involving antibiotic treatment may be authorized after verification of the absence of interference between the two trials in terms of safety and methodology);
Persons held in an institution by legal or official order, Patients under legal protection, Patients under guardianship or curatorship;
Patients unable to give a free and informed consent
Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Clinical cure without relapse at Day 30, defined by the absence of all the following: Local and/or general signs of infection, Relapse of bacteremia to S. aureus ; In dalbavancin arm: Any additional antibiotic therapy active on S. aureus received between DAY 0 and DAY 14  In both arms: Any additional antibiotic therapy active on S. aureus received after DAY 14; i.e. between DAY 14 and DAY 30, Deep focus infection including endocarditis, Death from all causes

Secondary endpoints 7

Clinical cure at DAY 14 and DAY 90 (EOS)
Death all-cause occurring within 90 days of follow-up
Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14
Autonomy, pain and anxiety using EQ-5D-5L scale at baseline (Day 0), DAY 14, DAY 30 and DAY 90 (EOS)
Hospitalization duration in days
Cost per avoided relapse, life-year gained, and per quality-adjusted life year (QALY)
Proportion of patients with any adverse event until EOS. It includes the complications due to venous catheterization

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Xydalba 500 mg powder for concentrate for solution for infusion

PRD9777205 · Product

Active substance: Dalbavancin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INFUSION
Max daily dose: 1500 mg milligram(s)
Max total dose: 1500 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J01XA04 — -
Marketing authorisation: EU/1/14/986/001
MA holder: ABBVIE DEUTSCHLAND GMBH & CO. KG
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 27

Oxacillin

SCP12525506 · ATC

Active substance: Oxacillin
Route of administration: INFUSION
Max daily dose: 12 g gram(s)
Max total dose: 168 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF04 — OXACILLIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Teicoplanin

SCP156605 · ATC

Active substance: Teicoplanin
Substance synonyms: Teichomycin A2
Route of administration: INTRAVENOUS INFUSION OR INTRAMUSCULAR INJECTION
Max daily dose: 6 mg/kg milligram(s)/kilogram
Max total dose: 84 mg/kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XA02 — TEICOPLANIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP40236661 · ATC

Route of administration: ORAL AND IV
Max daily dose: 900 mg milligram(s)
Max total dose: 12600 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01MA23 — DELAFLOXACIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ciprofloxacin Hydrochloride

SCP12479042 · ATC

Active substance: Ciprofloxacin Hydrochloride
Route of administration: ORAL AND IV
Max daily dose: 1200 mg milligram(s)
Max total dose: 16800 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01MA02 — CIPROFLOXACIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tigecycline

SCP236843 · ATC

Active substance: Tigecycline
Route of administration: INFUSION
Max daily dose: 100 mg milligram(s)
Max total dose: 750 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01AA12 — TIGECYCLINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP188790 · ATC

Route of administration: ORAL
Max daily dose: 3000 mg milligram(s)
Max total dose: 42000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FG01 — PRISTINAMYCIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cloxacillin

SCP102640673 · ATC

Active substance: Cloxacillin
Route of administration: INFUSION
Max daily dose: 12 g gram(s)
Max total dose: 168 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CF02 — CLOXACILLIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Piperacillin Sodium

SCP1153878 · ATC

Active substance: Piperacillin Sodium
Route of administration: INFUSION
Max daily dose: 16 g gram(s)
Max total dose: 224 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CR05 — PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lymecycline

SCP180930 · ATC

Active substance: Lymecycline
Route of administration: ORAL
Max daily dose: 600 mg milligram(s)
Max total dose: 8400 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01AA04 — LYMECYCLINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ceftriaxone Sodium

SCP107121969 · ATC

Active substance: Ceftriaxone Sodium
Route of administration: INFUSION
Max daily dose: 2 g gram(s)
Max total dose: 28 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DD04 — CEFTRIAXONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ambroxol Hydrochloride

SCP12713491 · ATC

Active substance: Ambroxol Hydrochloride
Substance synonyms: TRANS-4-[(2-AMINO-3,5-DIBROMOBENZYL) AMINO] CYCLOHEXANOL HYDROCHLORIDE
Route of administration: ORAL AND IV
Max daily dose: 200 mg milligram(s)
Max total dose: 1500 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01AA02 — DOXYCYCLINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amikacin Sulfate

SCP108746144 · ATC

Active substance: Amikacin Sulfate
Substance synonyms: AMIKACIN SULPHATE
Route of administration: INTRAVENOUS
Max daily dose: 45 mg/kg milligram(s)/kilogram
Max total dose: 45 mg/Kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01GB06 — AMIKACIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amoxicillin Sodium

SCP10330863 · ATC

Active substance: Amoxicillin Sodium
Route of administration: ORAL AND IV
Max daily dose: 12 g gram(s)
Max total dose: 168 mg/kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CA04 — AMOXICILLIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP133789 · ATC

Route of administration: ORAL AND IV
Max daily dose: 1000 mg milligram(s)
Max total dose: 14000 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01MA12 — LEVOFLOXACIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bromhexine Hydrochloride

SCP1166649 · ATC

Active substance: Bromhexine Hydrochloride
Route of administration: ORAL AND IV
Max daily dose: 2400 mg milligram(s)
Max total dose: 33600 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefazolin Sodium

SCP107201252 · ATC

Active substance: Cefazolin Sodium
Route of administration: INFUSION
Max daily dose: 3 g gram(s)
Max total dose: 42 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DB04 — CEFAZOLIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Linezolid

SCP13835914 · ATC

Active substance: Linezolid
Route of administration: ORAL AND IV
Max daily dose: 1200 mg milligram(s)
Max total dose: 16800 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XX08 — LINEZOLID
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clindamycin Hydrochloride

SCP1004780 · ATC

Active substance: Clindamycin Hydrochloride
Route of administration: ORAL AND IV
Max daily dose: 2400 mg milligram(s)
Max total dose: 33600 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01FF01 — CLINDAMYCIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP128018 · ATC

Route of administration: ORAL AND IV
Max daily dose: 600 mg milligram(s)
Max total dose: 8400 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01MA01 — OFLOXACIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daptomycin

SCP108760575 · ATC

Active substance: Daptomycin
Route of administration: INFUSION
Max daily dose: 6 mg/kg milligram(s)/kilogram
Max total dose: 84 mg/kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XX09 — DAPTOMYCIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP1935197 · ATC

Route of administration: ORAL
Max daily dose: 200 mg milligram(s)
Max total dose: 2800 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XX11 — TEDIZOLID
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ceftaroline Fosamil

SCP242269 · ATC

Active substance: Ceftaroline Fosamil
Route of administration: INFUSION
Max daily dose: 1800 mg milligram(s)
Max total dose: 25200 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DI02 — CEFTAROLINE FOSAMIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vancomycin

SCP148257 · ATC

Active substance: Vancomycin
Substance synonyms: VANCOMYCINUM
Route of administration: INFUSION
Max daily dose: 6 g gram(s)
Max total dose: 84 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01XA01 — VANCOMYCIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amoxicillin Sodium

SCP109545371 · ATC

Active substance: Amoxicillin Sodium
Route of administration: ORAL AND IV
Max daily dose: 600 mg milligram(s)
Max total dose: 8400 mg milligram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01CR02 — AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rifampicin

SCP135738 · ATC

Active substance: Rifampicin
Substance synonyms: RIFAMPIN
Route of administration: ORAL AND IV
Max daily dose: 30 mg/kg milligram(s)/kilogram
Max total dose: 420 mg/kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J04AB02 — RIFAMPICIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Betamethasone Valerate

SCP12505097 · ATC

Active substance: Betamethasone Valerate
Substance synonyms: BETAMETHASONE 17-VALERATE
Route of administration: INFUSION
Max daily dose: 8 mg/kg milligram(s)/kilogram
Max total dose: 8 mg/kg milligram(s)/kilogram
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01GB03 — GENTAMICIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefotaxime

SCP1143957 · ATC

Active substance: Cefotaxime
Route of administration: INFUSION
Max daily dose: 6 g gram(s)
Max total dose: 86 g gram(s)
Max treatment duration: 14 Day(s)
Authorisation status: Authorised
ATC code: J01DD01 — CEFOTAXIME
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: Dr Bernard CASTAN

Public contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Dr Bernard CASTAN

Locations

1 EU/EEA country · 34 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	406	34
Rest of world	—	0	—

Investigational sites

France

34 sites · Ongoing, recruiting

Centre Hospitalier Notre Dame De La Misericorde

Maladies Infectieuses et Tropicales, Route A Madunuccia, 20090, Ajaccio

Assistance Publique Hopitaux De Paris

Maladies Infectieuses et Tropicales, 27 Rue Du Faubourg Saint Jacques, 75014, Paris

Centre Hospitalier Universitaire Grenoble Alpes

Maladies infectieuses et tropicales, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9

Centre Hospitalier Universitaire De Dijon

Maladies Infectieuses et Tropicales, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon

Centre Hospitalier Universitaire De Rennes

Infectious Diseases Department, 2 Rue Henri Le Guilloux, 35000, Rennes

Centre Hospitalier De Pau

Infectiologie et maladies infectieuses, 4 Boulevard Hauterive, Cs 17595, Pau Cedex

Centre Hospitalier De La Cote Basque

Maladies Infectieuses et Tropicales, 13 Avenue Interne Jacques Loeb, 64100, Bayonne

Assistance Publique Hopitaux De Paris

Maladies Infectieuses et Tropicales, 2 Rue Ambroise Pare, 75475, Paris Cedex 10

Reseau De Sante Mutualiste

Maladies infectieuses, 158 Rue Leon Blum, 69100, Villeurbanne

Centre Hospitalier Metropole Savoie

Maladies Infectieuses, Place Lucien Biset, Bp 31125, Chambery

Centre Hospitalier Regional Et Universitaire De Brest

Maladies Infectieuses et Tropicales, Boulevard Tanguy Prigent, 29200, Brest

University Hospital Of Clermont-Ferrand

Maladies infectieuses et tropicales, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1

Assistance Publique Hopitaux De Paris

Maladies Infectieuses et Tropicales, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre

Centre Hospitalier De Perigueux

Maladies Infectieuses et Tropicales, 80 Avenue Georges Pompidou, 24000, Perigueux

Centre Hospitalier Universitaire De Saint Etienne

Maladies Infectieuses et Tropicales, Avenue Albert Raimond, 42270, Saint Priest En Jarez

Assistance Publique Hopitaux De Paris

Immunologie clinique et maladies infectieuses, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex

Assistance Publique Hopitaux De Paris

Maladies infectieuses, 47 Boulevard De L Hopital, 75651, Paris Cedex 13

Centre Hospitalier Universitaire De Poitiers

Maladies Infectieuses et Tropicales, 2 Rue De La Miletrie, 86000, Poitiers

Medipole Hopital Prive

Maladies infectieuses, 158 Rue Leon Blum, Cs 60279, Villeurbanne Cedex

Assistance Publique Hopitaux De Paris

Maladies Infectieuses et Tropicales, 104 Boulevard Raymond Poincare, 92380, Garches

Assistance Publique Hopitaux De Paris

Maladies Infectieuses et Tropicales, 46 Rue Henri Huchard, 75877, Paris Cedex 18

Centre Hospitalier Jean Rougier

Maladies Infectieuses et Tropicales, 52 Place Antonin Bergon, Bp 50269, Cahors

Centre Hospitalier Departemental Vendee

Maladies Infectieuses et Tropicales, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9

Centre Hospitalier De Brive

Maladies infectieuses, 1 Boulevard Du Docteur Verlhac, 19100, Brive La Gaillarde

Assistance Publique Hopitaux De Paris

Maladies Infectieuses et Tropicales, 9 Avenue Charles De Gaulle, 92100, Boulogne-Billancourt

Centre Hospitalier Universitaire De Toulouse

Maladies infectieuses et tropicales, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse

Centre Hospitalier Universitaire De Montpellier

Maladies Infectieuses et Tropicales, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Centre Hospitalier Universitaire De Nimes

Maladies Infectieuses et Tropicales, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9

Centre Hospitalier Universitaire De Caen Normandie

Maladies Infectieuses et Tropicales, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9

Centre Hospitalier Regional Universitaire De Tours

Médecine interne, 2 Boulevard Tonnelle, 37044, Tours Cedex 9

Centre Hospitalier Intercommunal De Cornouaille

Maladies Infectieuses et Tropicales, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex

Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources

Maladies Infectieuses et Tropicales, Avenue Pierre De Coubertin, Bp 417, Mont-De-Marsan Cedex

Centre Hospitalier Annecy Genevois

Maladies Infectieuses et Tropicales, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex

Assistance Publique Hopitaux De Paris

Maladies Infectieuses et Tropicales, 1 Avenue Claude Vellefaux, 75010, Paris

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	2023-06-23		2023-06-23

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 43 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D_FORM-EIG_2024-514952-34-00	2
Protocol (for publication)	D_FORM-GROSSESSE_2024-514952-34-00	1
Protocol (for publication)	D_LISTE-ANTIBIO_2024-514952-34-00	1
Protocol (for publication)	D_LISTE-INVESTIGATEURS_2024-514952-34-00	4
Protocol (for publication)	D1_Protocol_2024-514952-34-00_public	9-0
Protocol (for publication)	D4_Patient facing documents_CARNET-HOPITAL	1
Protocol (for publication)	D4_Patient facing documents_CARNET-VILLE	1
Protocol (for publication)	D4_Patient facing documents_CARTE-PATIENT	1
Protocol (for publication)	D4_Patient facing documents_EQ5D5S-score	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_NI-DONNEES	1-0
Subject information and informed consent form (for publication)	L1_SIS and ICF_NIFC-ADULTE	3-0
Subject information and informed consent form (for publication)	L1_SIS and ICF_NIFC-POURSUITE	1-0
Subject information and informed consent form (for publication)	L1_SIS and ICF_NIFC-PROCHE	1-0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_AMIKACINE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_BACTRIM	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CEFAZOLINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CEFOTAXIME	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CEFTRIAXONE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CIPROFLOXAXINE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CLINDAMYCINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CLOXACILLINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_CUBICIN	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_GENTAMICINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_LEVMENTIN	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_LEVOFLOXACINE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_LINEZOLIDE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_LYMECYCLINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_OFLOXACINE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_OXACILLINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_PIPERACILLINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_PYOSTACINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_QUOFENIX	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_RIFADINE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_SIVEXTRO	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_TARGOCID	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_TAZOCILLINE	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_TYGACIL	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_VANCOMYCINE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_VIBRAVEINEUSE	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_ZINFORO	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC-XYDALBA	2
Synopsis of the protocol (for publication)	D1_Protocol-synopsis-FR_2024-514952-34-00	9-0

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-07-24	France	Acceptable 2024-09-12	2024-09-12
2	SUBSTANTIAL MODIFICATION	SM-1	2025-02-24	France	Acceptable 2025-04-23	2025-04-23
3	NON SUBSTANTIAL MODIFICATION	NSM-2	2026-03-17	France	Acceptable 2025-04-23	2026-03-17