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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Médecine intensive - réanimation - CHU Amiens-Picardie
ACTIVE_NOT_RECRUITING
Amiens
Réanimation polyvalente - CH d'Argenteuil - Hôpital Victor Dupuy
RECRUITING
Argenteuil
Réanimation polyvalente - CH Avignon
RECRUITING
Avignon
Médecine intensive - réanimation - CHU Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
Médecine intensive - réanimation - Ambroise Paré
RECRUITING
Boulogne-billancourt
Médecine intensive - réanimation - CHU Gabriel Montpied
RECRUITING
Clermont-ferrand
Anesthésie - Réanimation - Beaujon
RECRUITING
Clichy
Réanimation polyvalente/Surveillance continue - CH Sud Essonne-Etampes
RECRUITING
Étampes
Médecine intensive - réanimation-Centre Hospitalier Départemental Vendée
RECRUITING
La Roche-sur-yon
Médecine intensive - réanimation - CHU Grenoble-Alpes Hôpital Michallon
RECRUITING
La Tronche
Réanimation polyvalente - CH de Versailles - Hôpital André Mignot
RECRUITING
Le Chesnay
Réanimation Médico Chirurgicale & USC - CH Le Mans
RECRUITING
Le Mans
Médecine intensive - réanimation - HCL - Edouard Herriot
RECRUITING
Lyon
Médecine Intensive Réanimation - Hôpital Croix Rousse
RECRUITING
Lyon
Réanimation polyvalente - CHR Metz-Thionville - Hôpital de Mercy
RECRUITING
Metz
Médecine intensive - réanimation - CHU Montpellier - Hôpital Lapeyronie
RECRUITING
Montpellier
Réanimation Chirurgicale - Saint Eloi
RECRUITING
Montpellier
Médecine intensive - réanimation - CHU Nice - Hôpital Archet
RECRUITING
Nice
Médecine Intensive Réanimation - Pasteur 2
RECRUITING
Nice
Anesthésie - Réanimation - CHU Orléans
RECRUITING
Orléans
Médecine intensive - réanimation
ACTIVE_NOT_RECRUITING
Orléans
Institut Mutualiste du Montsouris
RECRUITING
Paris
Médecine intensive et réanimation infectieuse - Bichat
RECRUITING
Paris
Réanimation chirurgicale - Bichat
RECRUITING
Paris
Médecine intensive - réanimation - CHU Poitiers - Site de la Milétrie
RECRUITING
Poitiers
Médecine intensive et réanimation polyvalente 6 CHU de Reims - Hôpital Robert Debré
NOT_YET_RECRUITING
Reims
Médecine intensive - réanimation-CH St Denis - Hôpital Delafontaine
RECRUITING
Saint-denis
Médecine intensive - réanimation - CHU de Strasbourg - Nouvel Hôpital Civil
RECRUITING
Strasbourg
Contact Information
Primary
Jean-François TIMSIT, MD-PhD
jean-françois.timsit@aphp.fr
01.40.25.77.07
Backup
Lila BOUADMA, MD-PhD
lila.bouadma@aphp.fr
01.40.25.77.07
Time Frame
Start Date: 2023-11-13
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 600
Treatments
Experimental: continuous infusion dosing of a pivotal AND AG infusion for 5 days
continuous infusion dosing of a pivotal βL-AB (CID group) AND AG infusion for 5 days (long duration) as appropriate combination therapy (ACT group)
Experimental: intermittent infusion dosing of a pivotal βL-AB ND AG infusion for 5 days
intermittent infusion dosing of a pivotal βL-AB (IID = control group) AND AG infusion for 5 days (long duration) as appropriate combination therapy (ACT = group)
Experimental: continuous infusion dosing of a pivotal βL-AB AND AG infusion at most 1 dose
continuous infusion dosing of a pivotal βL-AB (CID group) AND AG infusion at most 1 dose (AMT group )
Experimental: intermittent infusion dosing of a pivotal βL-AB AND AG infusion at most 1 dose
intermittent infusion dosing of a pivotal βL-AB (IID = group) AND AG infusion at most 1 dose (AMT group)
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov