Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol

2024-516232-10-00 Protocol LOCAL/2024/CR-03 Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 6 sites · Protocol LOCAL/2024/CR-03

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 1,250
Countries 1
Sites 6

Serious infections in critically ill patients treated with antibiotics

1. To describe the achievement of therapeutic antibiotic exposures (concentrations) in critically ill patients

Key facts

Sponsor
Centre Hospitalier Universitaire De Nimes
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Decision date (initial)
2025-10-17
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
CHU de Nîmes · University of Queensland Centre for Clinical Research (UQCCR)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Pharmacodynamic

1. To describe the achievement of therapeutic antibiotic exposures (concentrations) in critically ill patients

Secondary objectives 5

  1. To describe the achievement of alternative target exposures for select antibiotics in critically ill patients, defined as: i. 50% fT>MIC, 50% fT>4xMIC, 100%fT>MIC and 100%fT>4xMIC for beta-lactam antibiotics. ii. In adults, a trough concentration of ≥15 mg/L, and 15 to 25 mg/L for vancomycin intermittent and continuous infusions. iii. In children, a trough concentration range of 15 to 20 mg/L for methicillin-resistant Staphylococcus aureus (MRSA) and 10 to 15 mg/L for non-MRSA.
  2. To determine the relationship between achievement of target antibiotic exposures and the following patient-related outcomes: i. Positive clinical outcome. ii. Negative clinical outcome. iii. Mortality at day 14 and day 30 after initiation of the study antibiotic. iv. ICU free days at day 30 after initiation of the study antibiotic. v. Emergence of antibiotic resistance
  3. To determine the proportion of critically ill patients whose observed antibiotic concentrations surpass the pre-defined values associated with toxicity
  4. To determine the frequency of suspected adverse drug eventsi and the relationship between antibiotic concentration and suspected adverse drug events.
  5. To describe the pharmacokinetic variability of individual antibiotics in ICU patients

Conditions and MedDRA coding

Serious infections in critically ill patients treated with antibiotics

VersionLevelCodeTermSystem organ class
21.0 PT 10061644 Antibiotic level therapeutic 100000004848

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 pharmacokinetic/pharmacodynamic (PK/PD) cohort study
Cohort of ICU patients treated with antibotics for infection. There is no change in the medical care of patients. Antibiotics choice and doses are defined by clinicians in charge of the patient, in line with current practice. Up to 3 blood samples per antibiotic studied in the study are collected via existing catheters for PK/PD assessments.
 2 None Single arm cohort study: Follow up of patients with infections in intensive care unit to describe whether contemporary antibiotic dosing for critically ill patients achieves pre-defined exposures associated with maximal activity.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. 1. Patient is admitted to an ICU
  2. 2. Patient receiving one of the specified intravenous antibiotics (see Table 2) for the treatment of infection
  3. 3. Suitable intravenous/intra-arterial access to facilitate sample collection
  4. 4. Corrected gestational age of patient ≥1 month.
  5. 5. The patient must have been administered the study antibiotic for at least 24 hours.
  6. 6. Informed consent to participate in the study.

Exclusion criteria 4

  1. 1. Patient’s death is deemed imminent and inevitable
  2. 2. Patients who have received the study antibiotic for a duration exceeding 96 hours without accompanying blood sample collection
  3. 3. Patient is in a period of exclusion from a previous study, or is already participating in another research study involving a drug or which may influence the primary endpoint
  4. The patient is under court protection or guardianship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint is the antibiotic PK/PD plasma target defined in Table 1 for each study drug. Antibiotic plasma concentrations will be measured as described in Section 10 of the protocol.

Secondary endpoints 5

  1. Alternative PK/PD targets: i. 50% fT>MIC, 50% fT>4xMIC, 100%fT>MIC and 100%fT>4xMIC for beta-lactam antibiotics. ii. In adults, a trough concentration of ≥15 mg/L, and 15 to 25 mg/L for vancomycin intermittent and continuous infusions. iii. In children, a trough concentration range of 15 to 20 mg/L for methicillin-resistant Staphylococcus aureus (MRSA) and 10 to 15 mg/L for non-MRSA.
  2. Correlation between targeted antibiotic plasma concentrations and i. Clinical success ii. Clinical failure iii. Mortality at day 14 and day 30 after initiation of the study antibiotic. iv. The number of ICU free days at day 30 after initiation of the study antibiotic. v. Identification of resistant organisms in the subsequent microbiological samples within 14 days of study antibiotic start.
  3. Proportion of patients whose observed antibiotic concentrations surpass the pre-defined values associated with toxicity
  4. Correlation between antibiotic plasma concentrations and the occurrence of adverse events
  5. Description of observed antibiotic plasma concentrations

Investigational products

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

Test 38

Bromhexine Hydrochloride

SCP1166649 · ATC

Active substance
Bromhexine Hydrochloride
Route of administration
INTRAVENOUS USE
Max daily dose
2.4 g gram(s)
Max total dose
50.4 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
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
INTRAVENOUS USE
Max daily dose
10 mg/Kg milligram(s)/kilogram
Max total dose
210 mg/kg milligram(s)/kilogram
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01GB03 — GENTAMICIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Benzylpenicillin Procaine

SCP104123707 · ATC

Active substance
Benzylpenicillin Procaine
Substance synonyms
PROCAINE BENZYLPENICILLIN, PENICILLIN G PROCAINE, PENICILLIN PROCAINE
Route of administration
INTRAVENOUS USE
Max daily dose
6 million IU million international units
Max total dose
126 million IU million international units
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01CE01 — BENZYLPENICILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftriaxone Sodium

SCP107121969 · ATC

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

Metronidazole

SCP1153368 · ATC

Active substance
Metronidazole
Route of administration
INTRAVENOUS USE
Max daily dose
1.5 g gram(s)
Max total dose
31.5 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01XD01 — METRONIDAZOLE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Amoxicillin Sodium

SCP109545371 · ATC

Active substance
Amoxicillin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 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

Ceftazidime

SCP13237974 · ATC

Active substance
Ceftazidime
Route of administration
INTRAVENOUS USE
Max daily dose
6 g gram(s)
Max total dose
126 g gram(s)
Max treatment duration
21 Day(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

Tazobactam

SCP11455928 · ATC

Active substance
Tazobactam
Route of administration
INTRAVENOUS USE
Max daily dose
6 g gram(s)
Max total dose
126 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DI54 — CEFTOLOZANE AND BETA-LACTAMASE INHIBITOR
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Linezolid

SCP13835914 · ATC

Active substance
Linezolid
Route of administration
INTRAVENOUS USE
Max daily dose
1.8 g gram(s)
Max total dose
37.8 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01XX08 — LINEZOLID
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Linezolid

SCP101876674 · ATC

Active substance
Linezolid
Route of administration
INTRAVENOUS USE
Max daily dose
6 g gram(s)
Max total dose
126 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DH02 — MEROPENEM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP42363678 · ATC

Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DI04 — CEFIDEROCOL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aztreonam

SCP18113964 · ATC

Active substance
Aztreonam
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DF01 — AZTREONAM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ciprofloxacin Hydrochloride

SCP12479042 · ATC

Active substance
Ciprofloxacin Hydrochloride
Route of administration
INTRAVENOUS USE
Max daily dose
1.5 g gram(s)
Max total dose
31.5 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01MA02 — CIPROFLOXACIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefepime Hydrochloride

SCP107177473 · ATC

Active substance
Cefepime Hydrochloride
Substance synonyms
Cefepime dihydrochloride
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DE01 — CEFEPIME
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tigecycline

SCP236843 · ATC

Active substance
Tigecycline
Route of administration
INTRAVENOUS USE
Max daily dose
200 mg milligram(s)
Max total dose
4200 mg milligram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01AA12 — TIGECYCLINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Amoxicillin Sodium

SCP10330863 · ATC

Active substance
Amoxicillin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
300 mg/kg milligram(s)/kilogram
Max total dose
6300 mg/Kg milligram(s)/kilogram
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01CA04 — AMOXICILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefazolin Sodium

SCP107201252 · ATC

Active substance
Cefazolin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DB04 — CEFAZOLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cilastatin

SCP40975146 · ATC

Active substance
Cilastatin
Substance synonyms
LSALT peptide
Route of administration
INTRAVENOUS USE
Max daily dose
2 g gram(s)
Max total dose
41 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DH56 — IMIPENEM, CILASTATIN AND RELEBACTAM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin Sodium

SCP1153878 · ATC

Active substance
Piperacillin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
420 mg milligram(s)
Max treatment duration
21 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

Amikacin Sulfate

SCP108746144 · ATC

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

—

SCP101105926 · ATC

Route of administration
INTRAVENOUS USE
Max daily dose
10 mg/kg milligram(s)/kilogram
Max total dose
210 mg/kg milligram(s)/kilogram
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01GB01 — TOBRAMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fosfomycin Calcium

SCP10319265 · ATC

Active substance
Fosfomycin Calcium
Route of administration
INTRAVENOUS USE
Max daily dose
16 g gram(s)
Max total dose
336 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01XX01 — FOSFOMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Piperacillin Sodium

SCP181265 · ATC

Active substance
Piperacillin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
12 g gram(s)
Max total dose
252 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01CA12 — PIPERACILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ertapenem Sodium

SCP109549648 · ATC

Active substance
Ertapenem Sodium
Substance synonyms
ERTAPENEM MONOSODIUM
Route of administration
INTRAVENOUS USE
Max daily dose
1 g gram(s)
Max total dose
21 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DH03 — ERTAPENEM
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 USE
Max daily dose
12 mg/kg milligram(s)/kilogram
Max total dose
252 mg/kg milligram(s)/kilogram
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01XA02 — TEICOPLANIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ceftazidime Pentahydrate

SCP107188009 · ATC

Active substance
Ceftazidime Pentahydrate
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DD02 — CEFTAZIDIME
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cloxacillin

SCP102640673 · ATC

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

Daptomycin

SCP108760575 · ATC

Active substance
Daptomycin
Route of administration
INTRAVENOUS USE
Max daily dose
12 mg/kg milligram(s)/kilogram
Max total dose
252 mg/Kg milligram(s)/kilogram
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01XX09 — DAPTOMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP105620723 · ATC

Route of administration
INTRAVENOUS USE
Max daily dose
12 million IU million international units
Max total dose
252 million IU million international units
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01XB01 — COLISTIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefotaxime

SCP1143957 · ATC

Active substance
Cefotaxime
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DD01 — CEFOTAXIME
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ampicillin Sodium

SCP104123525 · ATC

Active substance
Ampicillin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01CR01 — AMPICILLIN AND BETA-LACTAMASE INHIBITOR
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Aztreonam

SCP107154634 · ATC

Active substance
Aztreonam
Route of administration
INTRAVENOUS USE
Max daily dose
8 g gram(s)
Max total dose
168 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DF51 — AZTREONAM AND BETA-LACTAMASE INHIBITOR
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cilastatin Sodium

SCP1166462 · ATC

Active substance
Cilastatin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
4 g gram(s)
Max total dose
84 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DH51 — IMIPENEM AND CILASTATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP111060923 · ATC

Route of administration
INTRAVENOUS USE
Max daily dose
1 g gram(s)
Max total dose
21 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01MA12 — LEVOFLOXACIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Meropenem

SCP32518756 · ATC

Active substance
Meropenem
Route of administration
INTRAVENOUS USE
Max daily dose
6 g gram(s)
Max total dose
126 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01DH52 — MEROPENEM AND VABORBACTAM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vancomycin

SCP121117533 · ATC

Active substance
Vancomycin
Substance synonyms
VANCOMYCINUM
Route of administration
INTRAVENOUS USE
Max daily dose
30 mg/kg milligram(s)/kilogram
Max total dose
630 mg/Kg milligram(s)/kilogram
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01XA01 — VANCOMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Flucloxacillin Sodium

SCP107974864 · ATC

Active substance
Flucloxacillin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
12 g gram(s)
Max total dose
252 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01CF05 — FLUCLOXACILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ampicillin Sodium

SCP106362797 · ATC

Active substance
Ampicillin Sodium
Route of administration
INTRAVENOUS USE
Max daily dose
12 g gram(s)
Max total dose
252 g gram(s)
Max treatment duration
21 Day(s)
Authorisation status
Authorised
ATC code
J01CA01 — AMPICILLIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nimes

15 Total trials 4 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Centre Hospitalier Universitaire De Nimes
Address
Place Du Professeur Robert Debre
City
Nimes Cedex 9
Postcode
30029
Country
France

Scientific contact point

Organisation
Centre Hospitalier Universitaire De Nimes
Contact name
Pr Claire ROGER

Public contact point

Organisation
Centre Hospitalier Universitaire De Nimes
Contact name
Christophe MASSEGUIN

Locations

1 EU/EEA country · 6 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 200 6
Rest of world
Taiwan, Israel, United Kingdom, Thailand, Brazil, United States, Chile, Singapore, Iran, Islamic Republic of, Kazakhstan, South Africa, Pakistan, Japan, Qatar, Australia, Vietnam, China, Hong Kong
 — 1,050 —

Investigational sites

France

6 sites · Authorised, recruitment pending
Centre Hospitalier Universitaire De Poitiers
Anesthésie - Réanimations, 2 Rue De La Miletrie, 86000, Poitiers
Hospices Civils De Lyon
Anesthésie - Réanimations, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Nimes
Anesthésie - Réanimations, Place Du Professeur Robert Debre, 30900, Nimes
Assistance Publique Hopitaux De Paris
Anesthésie - Réanimations, 46 Rue Henri Huchard, 75877, Paris Cedex 18
CHRU De Nancy
Anesthésie - Réanimations, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Hopital Beaujon
Anesthésie - Réanimations, 100 Boulevard Du General Leclerc, 92110, Clichy

Results and documents

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

Documents 48 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_FR_2024-516232-10-00 2
Recruitment arrangements (for publication) K1_Document_additionnel_2024-516232-10-00 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_2024-516232-10-00 1
Subject information and informed consent form (for publication) L1_SIS and ICF Patient_2024-516232-10-00 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF Patient_2024-516232-10-00_trackchange 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF Poursuite patient_2024-516232-10-00 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF Poursuite Patient_2024-516232-10-00_trackchange 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF Poursuite proche_2024-516232-10-00 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF Proche_2024-516232-10-00 1.2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_AMIKACINE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_AMOXICILLINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_AMPICILLINE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_AVIBACTAM_AZTREONAM 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_AVIBACTAM_CEFTAZIDIME 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_AZTREONAM 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_BENZYLPENICILLIN 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CEFAZOLINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CEFEPIME 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CEFIDEROCOL 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CEFTAZIDIME 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CEFTAZIDIME 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CEFTOLOZANE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CEFTRIAXONE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CIPROFLOXACINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CLAVULANATE_AMOXICILLINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_CLOXACILLINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_COLISTINE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_DAPTOMYCINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_ERTAPENEM 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_FLUCLOXACILLINE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_FOSFOMYCINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_GENTAMICINE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_IMIPENEM 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_LEVOFLOXACINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_LINEZOLIDE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_MEROPENEM 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_METRONIDAZOLE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_PIPERACILLINE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_RELEBACTAM_IMIPENEM_CILASTATIN 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_SULBACTAM_AMPICILLINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_TAZOBACTAM_PIPERACILLINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_TEICOPLANINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_TIGECYCLINE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_TOBRAMYCINE 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_TRIMETHOPRIME_SULFAMETHOXAZOLE 2
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_VABORBACTAM_MEROPENEM 1
Summary of Product Characteristics (SmPC) (for publication) G2_RCP_VANCOMYCINE 1
Synopsis of the protocol (for publication) D1_SYNOPSIS_FR_2024-516232-10-00 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-06-23 France Acceptable
2025-10-13
 2025-10-17

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