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New trial aims to find best way to give antibiotics for sepsis

NCT ID NCT05681442

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study looks at 600 ICU patients with hospital-acquired sepsis to see if giving antibiotics continuously or adding a second antibiotic improves survival. Patients will be randomly assigned to receive a beta-lactam antibiotic either continuously or intermittently, and some will also get an aminoglycoside antibiotic for one day or five days. The main goal is to compare 30-day death rates between the groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
beta-lactam antibiotics (given continuously or intermittently) and aminoglycoside antibiotics (given as a single dose or for 5 days)
What this could lead to
If successful, this could show that continuous antibiotic infusion or adding a second antibiotic improves survival in sepsis patients in the ICU.
What could go wrong
This is a Phase 4 trial, but sepsis is complex and results may not apply to all patients. The open-label design could introduce bias, and the benefit may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis

Contacts and locations

Locations

  • Anesthésie - Réanimation - Beaujon

    Clichy, 92110, France

  • Anesthésie - Réanimation - CHU Orléans

    Orléans, 86000, France

  • Institut Mutualiste du Montsouris

    Paris, France

  • Médecine Intensive Réanimation - Hôpital Croix Rousse

    Lyon, 69004, France

  • Médecine Intensive Réanimation - Pasteur 2

    Nice, 06100, France

  • Médecine intensive - réanimation

    Orléans, 45000, France

  • Médecine intensive - réanimation - Ambroise Paré

    Boulogne-Billancourt, 92100, France

  • Médecine intensive - réanimation - CHU Bordeaux - Hôpital Pellegrin

    Bordeaux, 33000, France

  • Médecine intensive - réanimation - CHU Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • Médecine intensive - réanimation - CHU Grenoble-Alpes Hôpital Michallon

    La Tronche, 38700, France

  • Médecine intensive - réanimation - CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34295, France

  • Médecine intensive - réanimation - CHU Nice - Hôpital Archet

    Nice, 06202, France

  • Médecine intensive - réanimation - CHU Poitiers - Site de la Milétrie

    Poitiers, 86000, France

  • Médecine intensive - réanimation - CHU de Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091, France

  • Médecine intensive - réanimation - HCL - Edouard Herriot

    Lyon, 69437, France

  • Médecine intensive - réanimation-CH St Denis - Hôpital Delafontaine

    Saint-Denis, 93200, France

  • Médecine intensive - réanimation-Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85000, France

  • Médecine intensive et réanimation infectieuse - Bichat

    Paris, 75018, France

  • Réanimation Chirurgicale - Saint Eloi

    Montpellier, 34295, France

  • Réanimation Médico Chirurgicale & USC - CH Le Mans

    Le Mans, 72037, France

  • Réanimation chirurgicale - Bichat

    Paris, 75018, France

  • Réanimation polyvalente - CH Avignon

    Avignon, 84000, France

  • Réanimation polyvalente - CH d'Argenteuil - Hôpital Victor Dupuy

    Argenteuil, 95100, France

  • Réanimation polyvalente - CH de Versailles - Hôpital André Mignot

    Le Chesnay, 78150, France

  • Réanimation polyvalente - CHR Metz-Thionville - Hôpital de Mercy

    Metz, 57085, France

  • Réanimation polyvalente/Surveillance continue - CH Sud Essonne-Etampes

    Étampes, 91150, France

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