Clinical trial • Phase IV • Infectious Disease

CEFEPIME for Prosthetic joint infection | Infection of osteosynthesis hardware

Phase IV trial of CEFEPIME for Prosthetic joint infection | Infection of osteosynthesis hardware.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Prosthetic joint infection | Infection of osteosynthesis hardware
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
03-02-2025

Trial design

Three arms: cefepime + daptomycin; piperacillin/tazobactam + daptomycin; ceftobiprole alone. (Doses indicated in product data: cefepime up to 6 g/day; piperacillin/tazobactam up to 12 g/day; ceftobiprole up to 1.5 g/day; daptomycin up to 6 mg/kg/day or up to 500 mg/day depending on presentation). No administration schedule specified in the record.-controlled Phase IV trial in France.

Comparator
Three arms: cefepime + daptomycin; piperacillin/tazobactam + daptomycin; ceftobiprole alone. (Doses indicated in product data: cefepime up to 6 g/day; piperacillin/tazobactam up to 12 g/day; ceftobiprole up to 1.5 g/day; daptomycin up to 6 mg/kg/day or up to 500 mg/day depending on presentation). No administration schedule specified in the record.
Target Sample Size
75
Trial Duration For Participant
5

Eligibility

Recruits 75 No vulnerable population selected; participants are adults (Age≥ 18) and provide informed consent. No assent or parental consent procedures are described in the record..

Vulnerable Population
No vulnerable population selected; participants are adults (Age≥ 18) and provide informed consent. No assent or parental consent procedures are described in the record.

Inclusion criteria

  • {"criterion_text":"- Age≥ 18 years old\n- Indication for prosthetic revision or total shoulder prosthesis or revision of internal osteosynthesis material with suspected IOAM\n- Normal CPK level according to the standard set by the laboratory"}

Exclusion criteria

  • {"criterion_text":"- Antibiotic therapy within the previous 3 months\n- Clinical or radiological signs making IOAM highly likely\n- Positive bacterial culture (strict pathogen) of a joint puncture prior to revision\n- Inflammatory bowel disease\n- Hypersensitivity to cefepime or to piperacillin+tazobactam or to ceftobiprole or any of the excipients or to other beta-lactam\n- Renal impairment with GFR < 50ml/min/1.73 m2 (CKD-EPI)\n- Treatment with bosentan and/or Probenecid treatment\n- Pre-existing seizure disorder"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The biodiversity of the gut microbiota will be determined from high-throughput sequencing data of bacterial 16S rDNA","definition_or_measurement_approach":"Determined from high-throughput sequencing data of bacterial 16S rDNA; diversity measured by targeted 16S rDNA metagenomics / high-throughput sequencing (as described in main objective)."}

Recruitment

Planned Sample Size
75
Recruitment Window Months
27
Consent Approach
Informed consent is required from adult participants (Age ≥ 18). Subject Information Sheet and Informed Consent Form for adults are provided (document titles: L1_SIS and ICF Adult_FP; additional subject information materials L2). No assent/parental consent described; French translations are present in the record.

Geography

Total Number Of Sites
4
Total Number Of Participants
75

France

Earliest CTIS Part Ii Submission Date
09-01-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
298
Number Of Sites
4
Number Of Participants
75

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Maladies Infectieuses et Tropicales
Principal Investigator Name
Johan COURJON
Principal Investigator Email
j.courjon@chu-nice.fr
Contact Person Name
Johan COURJON
Contact Person Email
j.courjon@chu-nice.fr
Site Name
Centre Hospitalier de Grasse
Department Name
Infectious Diseases
Principal Investigator Name
Cécile CAISSO
Principal Investigator Email
c.caisso@ch-grasse.fr
Contact Person Name
Cécile CAISSO
Contact Person Email
c.caisso@ch-grasse.fr
Site Name
Centre Hospitalier De Cannes Simone Veil
Department Name
Médecine Interne Infectiologie
Principal Investigator Name
Matteo VASSALLO
Principal Investigator Email
m.vassallo@ch-cannes.fr
Contact Person Name
Matteo VASSALLO
Contact Person Email
m.vassallo@ch-cannes.fr
Site Name
Centre Hospitalier D'Antibes Juan Les Pins
Department Name
Infectious Diseases
Principal Investigator Name
Eric DENIS
Principal Investigator Email
Eric.denis@ch-antibes.fr
Contact Person Name
Eric DENIS
Contact Person Email
Eric.denis@ch-antibes.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Nice
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
CEFEPIME VIATRIS 2 g, poudre pour solution injectable
Active Substance
CEFEPIME
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
6 g/day
Investigational Product Name
MABELIO 500 mg, poudre pour solution à diluer pour solution pour perfusion
Active Substance
CEFTOBIPROLE MEDOCARIL SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS PERFUSION USE
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
1.5 g/day
Investigational Product Name
Daptomycin Xellia 350 mg powder for solution for injection/infusion
Active Substance
DAPTOMYCIN
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
6 mg/kg/day
Investigational Product Name
Piperacillin/Tazobactam Viatris 4 g/0.5 g, powder for solution for infusion
Active Substance
PIPERACILLIN, TAZOBACTAM
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
12 g/day
Investigational Product Name
Daptomycin Xellia 500 mg powder for solution for injection/infusion
Active Substance
DAPTOMYCIN
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
500 mg/day
Combination Treatment
Yes

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