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BICCS - Beta-lactam Intermittent versus Continuous infusion and Combination antibiotic therapy in Sepsis
EU CTIS ID: 2024-516849-39-01
What this study is testing
To compare the 30-day mortality of patients with hospital-acquired sepsis in the ICU according to the mode of administration of the pivotal βL antibiotic (CID group vs. IID group).
- Therapeutic confirmatory (Phase III)
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
- • Adults (≥ 18 years) • Hospital-acquired sepsis (according to sepsis 3.0 definitions) - Patient hospitalized for more than 48 hours OR Patient discharged less than 48 hours ago - AND sepsis diagnosed within the last 24 hours
- •One of the following risk factors for gram negative multidrug resistant pathogens: -Prior intravenous antibiotic use within 7 days prior to sepsis onset with the exception of antibiotic effective only against Gram-positive bacteria, penicillin A and macrolides -Prolonged hospital stay (≥ 15 days of hospitalization) within 3 months prior to sepsis onset Prolonged mechanical ventilation (≥ 5 days on mechanical ventilation) within 3 months prior to sepsis onset-Patients with indwelling devices (dialysis access lines, intravascular lines, urinary catheter, endotracheal or tracheostomy tube, gastrostomy or jejunostomy feeding tube)
- - Patients known to be infected, colonized or carriers of MDR gram negative bacteria within 3 months prior to sepsis onset - Exposure to an antibiotic (amoxicillin-clavulanic acid, C2G, C3G, fluoroquinolones) within 3 months prior to sepsis onset - A trip abroad to known geographical areas at risk (in particular the Indian subcontinent, South-East Asia, the Middle East and North Africa, the Mediterranean Basin) within 3 months prior to sepsis onset - A functional or organic abnormality of the urinary tract in case of urinary tract infection. • Appropriate bacteriological sampling performed before starting antimicrobial therapy • Expected stay in ICU of more than 3 days
You likely can't join if
- • A priori known resistance to all the proposed beta-lactams or to amikacin Need for extrarenal treatment at inclusion according to the criteria of Gaudry et al. • Known hypersensitivity to ceftazidime, piperacillin-tazobactam, cefepime, meropenem, ceftazidime-avibactam, ceftazolane-avibactam or to any of the excipients included in the corresponding pharmaceutical drugs, • Known hypersensitivity to any cephalosporin antibacterial agent, • Know hypersentitivity to any penem antibacterial agent,
- • Severe known hypersensitivity (eg, anaphylactic reaction, severe skin reaction) to any other beta-lactam antibiotic (eg, penicillins or monobactam ) or to any of its excipients. • Known contraindication to the aminoglycoside family including o Hypersensitivity to the active substance, to any aminoglycoside antibacterial agent or to any of the excipients included in the corresponding pharmaceutical drugs, o Cirrhosis of grades B and C according to the Child-Pugh classification. o Myasthenia gravis. o Simultaneous administration of another aminoglycoside o Association with ataluren
- • Non-complicated urinary tract infection (corresponding to a positive ECBU not responsible for sepsis) • Bone marrow transplant or chemotherapy-induced neutropenia • Infections for which long-term antibiotic treatment > 8 days is strongly recommended (i.e., infective endocarditis, osteoarticular infections, anterior mediastinitis after cardiac surgery, hepatic or cerebral abscesses, chronic prostatitis for instance • Presence of antibiotic therapy for the new sepsis (if sepsis acquired in the hospital outside the resuscitation> 2 doses of antibiotics or > 16h for continuous infusion)
- • Limitation of life support (comfort care applied only) at the time of screening • Enrolment to another interventional drug study • Pregnancy or breastfeeding • Subject deprived of freedom, subject under a legal protective measure • Non affiliation to any health insurance system • Refusal to participate to the study (patient or legal representative or family member or close relative if present)
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.