BridgeMD
New treatment option for Sepsis
Official title Aminoglycosides in Early Sepsis
ClinicalTrials.gov ID: NCT06712641
What this study is testing
What is Gentamicin + narrow spectrum betalactam?
Gentamicin + narrow spectrum betalactam is an investigational medicine, being studied as a potential treatment for sepsis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. However, fear of renal complications due to gentamicin and concern for lacking evidence for efficiency commonly leads to the use of broad spectrum betalactam therapy, a larger driver of antibiotic resistance.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Hospitalized
- Adults 18 year or older
- Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy
- National Early Warning Score 2 (NEWS2) ≥ 5
- Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations
You likely can't join if
- Established chronic kidney failure (eGFR \< 30 ml/min/1.73m2)
- Presentation with septic shock with multiorgan failure
- Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial...
- Current or recent use of nephrotoxic drugs (e.g cisplatin within previous 2 months)
- Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria, methicillin-resistant Staphylococcus aureus (MRSA), or...
- Multiple myeloma
See the full eligibility criteria
- Hospitalized
- Adults 18 year or older
- Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy
- National Early Warning Score 2 (NEWS2) ≥ 5
- Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations
- Established chronic kidney failure (eGFR \< 30 ml/min/1.73m2)
- Presentation with septic shock with multiorgan failure
- Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial infection)
- Current or recent use of nephrotoxic drugs (e.g cisplatin within previous 2 months)
- Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria, methicillin-resistant Staphylococcus aureus (MRSA), or other drug-resistant microbes necessitating specific antimicrobial...
- Multiple myeloma
- Renal transplantation
- Renal replacement therapy
- Myasthenia gravis
- Known hypersensitivity to any of the study drugs
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Bergen, Norway
- Oslo, Oslo, Norway
- Trondheim, Trondheim, Norway
- Lørenskog, Norway
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Bergen, Norway; Oslo, Oslo, Norway; Trondheim, Trondheim, Norway; Lørenskog, Norway; Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.