Clinical trial • Not applicable • Infectious Disease

Gentamicin sulfate for Sepsis

Not applicable trial of Gentamicin sulfate for Sepsis.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Sepsis
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-03-2025
First CTIS Authorization Date
01-07-2025

Trial design

Randomised, open-label, piperacillin–tazobactam (piperacillin sodium + tazobactam sodium) — dose/schedule not specified; cefotaxime — dose/schedule not specified-controlled Not applicable trial across 5 sites in Norway.

Randomised
Yes
Open Label
Yes
Comparator
Piperacillin–tazobactam (piperacillin sodium + tazobactam sodium) — dose/schedule not specified; Cefotaxime — dose/schedule not specified
Target Sample Size
2000
Trial Duration For Participant
30

Eligibility

Recruits 2000 No vulnerable population selected. Informed consent must be obtained and documented according to ICH GCP and national/local regulations. Subject information and informed consent form (SIS and ICF) variants included (normal, delayed, next-of-kin, delayed next-of-kin, reservation and reservation next-of-kin), indicating processes for delayed consent and next-of-kin consent when needed..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
No vulnerable population selected. Informed consent must be obtained and documented according to ICH GCP and national/local regulations. Subject information and informed consent form (SIS and ICF) variants included (normal, delayed, next-of-kin, delayed next-of-kin, reservation and reservation next-of-kin), indicating processes for delayed consent and next-of-kin consent when needed.

Inclusion criteria

  • {"criterion_text":"- Hospitalized"}
  • {"criterion_text":"- Adults 18 year or older"}
  • {"criterion_text":"- Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy"}
  • {"criterion_text":"- National Early Warning Score 2 (NEWS2) ≥ 5"}
  • {"criterion_text":"- Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations"}

Exclusion criteria

  • {"criterion_text":"- Established chronic kidney failure (eGFR < 30 ml/min/1.73m2)"}
  • {"criterion_text":"- Presentation with septic shock with multiorgan failure"}
  • {"criterion_text":"- Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial infection)"}
  • {"criterion_text":"- Current or recent use of nephrotoxic drugs (e.g cisplatin within previous 2 months)"}
  • {"criterion_text":"- Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria, methicillin-resistant Staphylococcus aureus (MRSA), or other drug-resistant microbes necessitating specific antimicrobial therapy"}
  • {"criterion_text":"- Multiple myeloma"}
  • {"criterion_text":"- Renal transplantation"}
  • {"criterion_text":"- Renal replacement therapy"}
  • {"criterion_text":"- Myasthenia gravis"}
  • {"criterion_text":"- Known hypersensitivity to any of the study drugs"}
  • {"criterion_text":"- Pregnancy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Death up to 30 days after randomization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Any acute kidney injury up to 30 days after randomization","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- In-hospital mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Mortality up to 30 days after discharge","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of hospital stay","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of intensive care stay","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of ventilator therapy","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of vasopressor therapy","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hospital readmissions up to 30 days after discharge","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of antibiotic treatment","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
2000
Recruitment Window Months
48
Consent Approach
Signed informed consent must be obtained and documented according to ICH GCP and national/local regulations. Participant provides consent (adults ≥18). ICF variants available for normal consent, delayed consent, next-of-kin consent, delayed next-of-kin consent, reservation and reservation next-of-kin; languages not specified.

Geography

Total Number Of Sites
5
Total Number Of Participants
2000

Norway

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
293
Number Of Sites
5
Number Of Participants
2000

Sites

Site Name
Oslo University Hospital HF
Department Name
Infectious diseases
Principal Investigator Name
Kristian Tonby
Principal Investigator Email
kritonby@ous-hf.no
Contact Person Name
Kristian Tonby
Contact Person Email
kritonby@ous-hf.no
Site Name
Akershus University Hospital
Department Name
Infectious diseases
Principal Investigator Name
Magnus Lyngbakken
Principal Investigator Email
magnus.lyngbakken@medisin.uio.no
Contact Person Name
Magnus Lyngbakken
Site Name
St. Olavs Hospital HF
Department Name
Department of Infectious Diseases
Principal Investigator Name
Birgitta Ehrnström
Principal Investigator Email
birgitta.ehrnstrom@ntnu.no
Contact Person Name
Birgitta Ehrnström
Contact Person Email
birgitta.ehrnstrom@ntnu.no
Site Name
Lovisenberg Diakonale Sykehus AS
Department Name
Department of Infectious Diseases
Principal Investigator Name
Hedda Hoel
Principal Investigator Email
HeddaBenedicte.Hoel@lds.no
Contact Person Name
Hedda Hoel
Contact Person Email
HeddaBenedicte.Hoel@lds.no
Site Name
Helse Bergen HF
Department Name
Department of Infectious Diseases
Principal Investigator Name
Oddvar Oppegaard
Principal Investigator Email
oddvar.oppegaard@helse-bergen.no
Contact Person Name
Oddvar Oppegaard

Sponsor

Primary sponsor

Full Name
Akershus University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Norway

Investigational products

Investigational Product Name
GENTAMICIN
Active Substance
Gentamicin sulfate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
700 mg
Investigational Product Name
AMPICILLIN
Active Substance
Ampicillin sodium
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
12 g
Investigational Product Name
CLOXACILLIN
Active Substance
Cloxacillin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
12 g
Investigational Product Name
BENZYLPENICILLIN
Active Substance
Benzathine benzylpenicillin; Benzylpenicillin potassium
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
18 g
Investigational Product Name
CEFOTAXIME
Active Substance
Cefotaxime (with lidocaine listed as excipient)
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
12 g
Investigational Product Name
PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
Active Substance
Piperacillin sodium; Tazobactam sodium
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
16 g
Combination Treatment
Yes

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