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Aminoglycosides in early sepsis
EU CTIS ID: 2024-519797-39-00
What this study is testing
In patients with suspected community acquired sepsis, assess whether combination therapy with narrow spectrum betalactam (penicillin, ampicillin, cloxacillin) and aminoglycoside (gentamicin) is safe and non-inferior to therapy with broad spectrum antibiotics (cefotaxime, piperacillin-tazobactam)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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)
- Known hypersensitivity to any of the study drugs
- Pregnancy
- 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)
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)
- Known hypersensitivity to any of the study drugs
- Pregnancy
- 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 therapy
- Multiple myeloma
- Renal transplantation
- Renal replacement therapy
- Myasthenia gravis
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.