Clinical trial • Infectious Disease

LINEZOLID for Staphylococcus aureus bacteremia

Clinical trial of LINEZOLID for Staphylococcus aureus bacteremia.

Overview

Trial Therapeutic Area: Infectious Disease
Trial Disease: Staphylococcus aureus bacteremia
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 16-01-2025
First CTIS Authorization Date: 30-01-2025

Trial design

Randomised, open-label, 7 days of antibiotic therapy versus 14 days of antibiotic therapy; specific drugs/doses for arms are not specified in the randomisation comparator description.-controlled trial in Denmark.

Randomised: Yes
Open Label: Yes
Comparator: 7 days of antibiotic therapy versus 14 days of antibiotic therapy; specific drugs/doses for arms are not specified in the randomisation comparator description.
Target Sample Size: 264
Trial Duration For Participant: 180

Eligibility

Recruits 264 No vulnerable population selected. Participants are adults (Age ≥ 18 years). Subject information and informed consent form(s) are provided (document present); no assent or paediatric consent procedures specified..

Pregnancy Exclusion: Pregnancy or breastfeeding
Vulnerable Population: No vulnerable population selected. Participants are adults (Age ≥ 18 years). Subject information and informed consent form(s) are provided (document present); no assent or paediatric consent procedures specified.

Inclusion criteria

{"criterion_text":"- Age ≥ 18 years"}
{"criterion_text":"- Blood culture positive for Staphylococcus aureus"}
{"criterion_text":"- Antibiotic treatment with antimicrobial activity to S. aureus administrated within 12 hours of the first positive blood culture"}
{"criterion_text":"- Temperature < 37,8 ᵒC (100°F) at randomization"}
{"criterion_text":"- S. aureus negative follow-up blood culture obtained 48-120 hours after microbiological verified SAB"}

Exclusion criteria

{"criterion_text":"- Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-120 hours of the first positive blood culture)"}
{"criterion_text":"- Pregnancy or breastfeeding"}
{"criterion_text":"- Neutropenia (blood neutrophils < 1,0 x 109/l)"}
{"criterion_text":"- Untreated terminal cancer"}
{"criterion_text":"- Chemotherapy within 30 days"}
{"criterion_text":"- Corticosteroid treatment (> 20 mg/day prednisone or the equivalent for > 14 days) within the last 30 days"}
{"criterion_text":"- Ongoing treatment with immunosuppressive agents (ATC code L04A)"}
{"criterion_text":"- Polymicrobial infection"}
{"criterion_text":"- Antibiotic treatment whit no antimicrobial activity to S. aureus administrated more than 12 hours of the first positive blood culture"}
{"criterion_text":"- Endocarditis or other intracardiac infection demonstrated with transthoracic or transesophageal echocardiography"}
{"criterion_text":"- Previous history of endocarditis or pacemaker/AICD infection"}
{"criterion_text":"- Failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture"}
{"criterion_text":"- Infection involving bone, joints or foreign bodies"}
{"criterion_text":"- Pneumonia requiring oxygen supply at randomization"}
{"criterion_text":"- S. aureus infection within the last 90 days"}

Endpoints

Primary endpoints

{"endpoint_text":"- 90-day survival without clinical or microbiological failure to treatment or relapse in patients treated with 7 days versus 14 days of antibiotic therapy","definition_or_measurement_approach":"Measured as survival status at 90 days post-diagnosis together with absence of clinical or microbiological failure to treatment or relapse within 90 days; follow-up to 90 days from diagnosis."}

Secondary endpoints

{"endpoint_text":"- All-cause mortality days 14, 28, 90 and 180","definition_or_measurement_approach":"All-cause mortality assessed at days 14, 28, 90 and 180 after diagnosis."}
{"endpoint_text":"- Microbiological failure to treatment","definition_or_measurement_approach":""}
{"endpoint_text":"- Microbiological relapse","definition_or_measurement_approach":""}
{"endpoint_text":"- Clinical failure to treatment","definition_or_measurement_approach":""}
{"endpoint_text":"- Severe adverse events grade ≥3","definition_or_measurement_approach":""}
{"endpoint_text":"- Severe adverse events grade ≥3","definition_or_measurement_approach":""}
{"endpoint_text":"- Clostridium difficile infection","definition_or_measurement_approach":""}
{"endpoint_text":"- Multidrug-resistance organism","definition_or_measurement_approach":""}
{"endpoint_text":"- Health-associated costs associated the treatment lengths","definition_or_measurement_approach":""}
{"endpoint_text":"- Desirability of outcome ranking (DOOR)","definition_or_measurement_approach":""}
{"endpoint_text":"- Hospital admissions during follow up","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size: 264
Recruitment Window Months: 125
Consent Approach: Informed consent obtained from adult participants (Age ≥ 18 years). Subject information and informed consent form(s) are provided (documents listed). No assent or paediatric consent procedures or languages specified in the available documents.

Geography

Total Number Of Sites: 8
Total Number Of Participants: 264

Denmark

Earliest CTIS Part Ii Submission Date: 28-01-2025
Latest Decision Or Authorization Date: 17-11-2025
Processing Time Days: 293
Number Of Sites: 8
Number Of Participants: 264

Sites

Site Name: Gentofte Hospital
Department Name: Department of Infectious Diseases
Contact Person Name: Pernielle Ravn
Contact Person Email: pernille.ravn.02@regionh.dk

Site Name: Bispebjerg Hospital
Department Name: Department of respiratory medicine and infectious diseases
Contact Person Name: Andreas Knudsen
Contact Person Email: jesper.andreas.knudsen@regionh.dk

Site Name: Herlev Hospital
Department Name: Department of Infectious Diseases
Contact Person Name: Suzanne Lunding
Contact Person Email: suzanne.lunding.01@regionh.dk

Site Name: Sygehus Sønderjylland, Aabenraa
Department Name: Department of Emergency Medicine
Contact Person Name: Theis Aagaard Sonnichsen
Contact Person Email: Theis.Aagaard.Sonnichsen@rsyd.dk

Site Name: Hillerod Hospital
Department Name: Department of respiratory medicine
Contact Person Name: Birgitte Lindegaard Madsen
Contact Person Email: birgitte.lindegaard.madsen@regionh.dk

Site Name: Odense University Hospital
Department Name: Department of Infectious Diseases
Contact Person Name: Isik Somuncu Johansen
Contact Person Email: isik.somuncu.johansen@rsyd.dk

Site Name: Kolding Hospital
Department Name: Department of Infectious Diseases
Contact Person Name: Janne Jensen
Contact Person Email: janne.jensen@rsyd.dk

Site Name: Hvidovre Hospital
Department Name: Department
Contact Person Name: Louise Thorlacius-Ussing
Contact Person Email: louise.thorlacius-ussing@regionh.dk

Sponsor

Primary sponsor

Full Name: Hvidovre Hospital
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", filmovertrukne tabletter
Active Substance: LINEZOLID
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 1200 mg

Investigational Product Name: Clarithromycin "Accord", filmovertrukne tabletter
Active Substance: CLARITHROMYCIN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 500 mg

Investigational Product Name: Moxifloxacin Fresenius Kabi
Active Substance: MOXIFLOXACIN HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 400 mg

Investigational Product Name: Daptomycin "Accord Healthcare", pulver til injektions-/infusionsvæske, opløsning
Active Substance: DAPTOMYCIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 10 mg/Kg

Investigational Product Name: Gentamicin "B. Braun", infusionsvæske, opløsning
Active Substance: GENTAMICIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 5 mg/Kg

Investigational Product Name: Cloxacillin "Stragen", pulver til injektions-/infusionsvæske, opløsning
Active Substance: CLOXACILLIN SODIUM
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 4 g

Investigational Product Name: Dicloxacillin "Alternova", hårde kapsler
Active Substance: DICLOXACILLIN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 4 g

Investigational Product Name: Amikacin "Macure", injektionsvæske, opløsning
Active Substance: AMIKACIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 15 mg/Kg

Investigational Product Name: Cefuroxim Fresenius Kabi
Active Substance: CEFUROXIME SODIUM
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 6000 mg

Investigational Product Name: Ertapenem Fresenius Kabi
Active Substance: ERTAPENEM SODIUM
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 1 g

Investigational Product Name: Primcillin, filmovertrukne tabletter 800 mg
Active Substance: PHENOXYMETHYLPENICILLIN POTASSIUM
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 3200 mg

Investigational Product Name: Piperacillin/Tazobactam "Sandoz"
Active Substance: PIPERACILLIN, TAZOBACTAM
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 16 g

Investigational Product Name: Bactocin, pulver til infusionsvæske, opløsning
Active Substance: VANCOMYCIN HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 2 g

Investigational Product Name: Clindamycin "Abcur", injektions-/infusionsvæske, opløsning
Active Substance: CLINDAMYCIN
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 1800 mg

Investigational Product Name: Meropenem Fresenius Kabi
Active Substance: MEROPENEM TRIHYDRATE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 2 g

Investigational Product Name: Ceftriaxon "Kalceks", pulver til injektions-/infusionsvæske, opløsning
Active Substance: CEFTRIAXONE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 2 g

Investigational Product Name: Benzylpenicillin "Panpharma", pulver til injektions- og infusionsvæske, opløsning
Active Substance: BENZYLPENICILLIN SODIUM
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 4 million IU

Investigational Product Name: Levofloxacin "Macure"
Active Substance: LEVOFLOXACIN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised
Maximum Dose: 1000 mg

Investigational Product Name: Cefotaxim "MIP", pulver til injektions-/infusionsvæske, opløsning
Active Substance: CEFOTAXIME
Modality: Small molecule
Routes Of Administration: INTRAVENOUS
Route: INTRAVENOUS
Authorisation Status: Authorised
Maximum Dose: 2 g

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: 1600 mg

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