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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis

Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis (NCT05681442) is a Phase 4 interventional studying Sepsis, sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. intermittent pivotal βL (Beta Lactamine) antibiotic infusion strategies and combination vs. monotherapy trial conducted with a 2X2 factorial design.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 600 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion 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 Exclusion Criteria: * 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 abscesses, chronic prostatitis for instance * 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 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)

Treatments Being Tested

DRUG

continuous pivotal βL-AB

continuous pivotal βL-AB

DRUG

intermittent pivotal βL-AB

intermittent pivotal βL-AB (IID = control group)

DRUG

AG infusion most 1 dose

AG infusion most 1 dose (AMT group )

DRUG

AG infusion for 5 days

AG infusion for 5 days (ACT Group)

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Médecine intensive - réanimation - CHU Amiens-Picardie
Amiens, France
Réanimation polyvalente - CH d'Argenteuil - Hôpital Victor Dupuy
Argenteuil, France
Réanimation polyvalente - CH Avignon
Avignon, France
Médecine intensive - réanimation - CHU Bordeaux - Hôpital Pellegrin
Bordeaux, France
Médecine intensive - réanimation - Ambroise Paré
Boulogne-Billancourt, France
Médecine intensive - réanimation - CHU Gabriel Montpied
Clermont-Ferrand, France
Anesthésie - Réanimation - Beaujon
Clichy, France
Réanimation polyvalente/Surveillance continue - CH Sud Essonne-Etampes
Étampes, France
Médecine intensive - réanimation-Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
Médecine intensive - réanimation - CHU Grenoble-Alpes Hôpital Michallon
La Tronche, France
Réanimation polyvalente - CH de Versailles - Hôpital André Mignot
Le Chesnay, France
Réanimation Médico Chirurgicale & USC - CH Le Mans
Le Mans, France
Médecine Intensive Réanimation - Hôpital Croix Rousse
Lyon, France
Médecine intensive - réanimation - HCL - Edouard Herriot
Lyon, France
Réanimation polyvalente - CHR Metz-Thionville - Hôpital de Mercy
Metz, France
Médecine intensive - réanimation - CHU Montpellier - Hôpital Lapeyronie
Montpellier, France
Réanimation Chirurgicale - Saint Eloi
Montpellier, France
Médecine Intensive Réanimation - Pasteur 2
Nice, France
Médecine intensive - réanimation - CHU Nice - Hôpital Archet
Nice, France
Médecine intensive - réanimation
Orléans, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05681442), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05681442 clinical trial studying?

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. intermittent pivotal βL (Beta Lactamine) antibiotic infusion strategies and combination vs. monotherapy trial conducted with a 2X2 factorial design. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05681442?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05681442?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05681442. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05681442. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.