Clinical trial • Phase IV • Infectious Disease|Other

LINEZOLID for Bacterial infection|Postoperative infection following cystectomy

Phase IV trial of LINEZOLID for Bacterial infection|Postoperative infection following cystectomy.

Overview

Trial Therapeutic Area: Infectious Disease|Other
Trial Disease: Bacterial infection|Postoperative infection following cystectomy
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 13-09-2024
First CTIS Authorization Date: 10-12-2024

Trial design

Randomised, open-label, pivmecillinam hydrochloride karo pharma 400 mg film-coated tablets; dose strength 400 mg (tablet); schedule not specified-controlled Phase IV trial across 5 sites in Denmark.

Randomised: Yes
Open Label: Yes
Comparator: Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets; dose strength 400 mg (tablet); schedule not specified
Target Sample Size: 248
Trial Duration For Participant: 90

Eligibility

Recruits 248 No vulnerable populations selected; participants must be able to understand and sign an informed consent..

Vulnerable Population: No vulnerable populations selected; participants must be able to understand and sign an informed consent.

Inclusion criteria

{"criterion_text":"- Age at surgery ≥ 18 years\n- Ability to understand and sign an informed consent\n- Malignant or benign indication for undergoing cystectomy\n- Planned ileal conduit as urinary diversion"}

Exclusion criteria

{"criterion_text":"- Previous severe allergic reaction to antimicrobial treatment\n- Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy"}

Endpoints

Primary endpoints

{"endpoint_text":"- 90-day infection-related hospital readmission rate","definition_or_measurement_approach":""}

Secondary endpoints

{"endpoint_text":"- Timing of ureteral stent removal and type of antimicrobial prophylaxis administered at ureteral stent removal","definition_or_measurement_approach":""}
{"endpoint_text":"- All-cause readmissions within 30 and 90 days after surgery, including main cause, timing, duration, microbiological tests, and antimicrobial treatment","definition_or_measurement_approach":""}
{"endpoint_text":"- Postoperative complications within 30 and 90 days of surgery using the Clavien-Dindo classification score","definition_or_measurement_approach":""}
{"endpoint_text":"- Days-alive-and-out-of-hospital (DAOH) at POD 30 and 90","definition_or_measurement_approach":""}
{"endpoint_text":"- Quality-of-life using the EORTC QLQ-C30 and QLQ-BLM30 questionnaires filled out preoperatively and on POD 90","definition_or_measurement_approach":""}
{"endpoint_text":"- Microbiological findings and antimicrobial susceptibility analyses in pre- and postoperative microbiological samples","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size: 248
Recruitment Window Months: 28
Consent Approach: Participants must be able to understand and sign an informed consent. Subject information and informed consent form documents are provided (documents available in the application). No assent or additional age-specific consent processes are described.

Geography

Total Number Of Sites: 5
Total Number Of Participants: 248

Denmark

Earliest CTIS Part Ii Submission Date: 20-11-2024
Latest Decision Or Authorization Date: 13-02-2026
Processing Time Days: 450
Number Of Sites: 5
Number Of Participants: 248

Sites

Site Name: Rigshospitalet
Department Name: Department of Urology
Contact Person Name: Andreas Røder
Contact Person Email: andreas.roeder@regionh.dk

Site Name: Odense University Hospital
Department Name: Department of Urology
Contact Person Name: Lars Lund
Contact Person Email: lars.lund@rsyd.dk

Site Name: Aalborg University Hospital
Department Name: Department of Urology
Contact Person Name: Astrid Helene Livbjerg
Contact Person Email: ahlm@rn.dk

Site Name: Herlev Hospital
Department Name: Department of Urology
Contact Person Name: Ann Kortbæk Bersang
Contact Person Email: ann.kortbaek.bersang@regionh.dk

Site Name: Aarhus University Hospital
Department Name: Department of Urology
Contact Person Name: Pernille Skjold Kingo
Contact Person Email: perkin@rm.dk

Sponsor

Primary sponsor

Full Name: Rigshospitalet
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Denmark

Third parties

{"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsor duties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name: Linezolid Teva 600 mg filmdragerade tabletter
Active Substance: LINEZOLID
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 1200 mg

Investigational Product Name: Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets
Active Substance: PIVMECILLINAM HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 1200 mg

Investigational Product Name: Nitrofurantoin 50 mg tablets
Active Substance: NITROFURANTOIN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 400 mg

Investigational Product Name: Zinnat 500 mg, tbl flm
Active Substance: CEFUROXIME AXETIL
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 1500 mg

Investigational Product Name: Ciprofloxacin 500 mg, film coated tablets
Active Substance: CIPROFLOXACIN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 1500 mg

Investigational Product Name: Bioclavid 500 mg/125 mg filmdragerade tabletter
Active Substance: AMOXICILLIN, CLAVULANIC ACID
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 3500 mg

Investigational Product Name: Amoxicillin 500 mg film-coated tablets
Active Substance: AMOXICILLIN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 3000 mg

Investigational Product Name: Trimopan, filmovertrukne tabletter
Active Substance: TRIMETHOPRIM
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 400 mg

Investigational Product Name: Fluconazole 200 mg Capsules
Active Substance: FLUCONAZOLE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 800 mg

Investigational Product Name: Sulfametoxazol med trimetoprim SAD, tabletter
Active Substance: SULFAMETHOXAZOLE, TRIMETHOPRIM
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 6400 mg

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