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Compares treatment options for Sepsis
Official title Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
ClinicalTrials.gov ID: NCT05681442
What this study is testing
What is continuous pivotal βL-AB?
continuous pivotal βL-AB is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sepsis.
Also referred to as CID group.
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
- Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) or septic shock presumably due to MDR-GNB (multidrug resistant Gram-negative bacteria). The study will be a prospective multicentre, randomized, open-label comparative continuous vs.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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
- 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:
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...
- 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 )...
See the full eligibility criteria
- 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
- 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
- Hypersensitivity to the active substance, to any aminoglycoside antibacterial agent or to any of the excipients included in the corresponding pharmaceutical drugs,
- Cirrhosis of grades B and C according to the Child-Pugh classification.
- Myasthenia gravis.
- Simultaneous administration of another aminoglycoside
- 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...
- Presence of antibiotic therapyfor the new sepsis before randomisation: (\> 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 treatment 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.
Where it's taking place
- Amiens, France
- Argenteuil, France
- Avignon, France
- Bordeaux, France
- Boulogne-Billancourt, France
- Clermont-Ferrand, France
- Clichy, France
- Étampes, France
- La Roche-sur-Yon, France
- La Tronche, France
- Le Chesnay, France
- Le Mans, France
- Lyon, France
- Metz, France
- Montpellier, France
- Nice, France
- Orléans, France
- Paris, France
- Poitiers, France
- Reims, France
+ 2 more site(s).
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 Amiens, France; Argenteuil, France; Avignon, France; Bordeaux, France; Boulogne-Billancourt, France; Clermont-Ferrand, France and 16 more location(s). 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.