Clinical trial • Phase IV • Infectious Disease
MEROPENEM TRIHYDRATE for Sepsis
Phase IV trial of MEROPENEM TRIHYDRATE for Sepsis. 988 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Sepsis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-06-2024
- First CTIS Authorization Date
- 30-09-2024
Trial design
Phase IV trial in Netherlands.
- Target Sample Size
- 988
- Trial Duration For Participant
- 365
Eligibility
Recruits 988 Patient or legal representative must be available to give informed consent within three days after admittance (exclusion criterion). Subject information and informed consent forms exist for adult patient and adult representative (documents: L1_SIS and ICF adult representative; L1_SIS and ICF adult patient). The trial does not select a vulnerable population (isVulnerablePopulationSelected: false)..
- Pregnancy Exclusion
- - Pregnancy
- Vulnerable Population
- Patient or legal representative must be available to give informed consent within three days after admittance (exclusion criterion). Subject information and informed consent forms exist for adult patient and adult representative (documents: L1_SIS and ICF adult representative; L1_SIS and ICF adult patient). The trial does not select a vulnerable population (isVulnerablePopulationSelected: false).
Inclusion criteria
- {"criterion_text":"- ≥18 years of age\n- Receiving intravenous antibiotic therapy of the target drugs (including continuous infusion of beta-lactam antibiotics)\n- Primary infection\n- Admitted to the ICU\n- Meeting the Sepsis-3 criteria for septic shock: sepsis in addition to shock requiring the start of vasopressors to maintain a mean arterial pressure 65 mm Hg or greater, and a serum lactate level greater than 2.0 mmol/L following “adequate fluid resuscitation”."}
Exclusion criteria
- {"criterion_text":"- Patient or legal representative not available to give informed consent within three days after admittance\n- Pregnancy\n- Admittance for burn wounds\n- Patients receiving target antibiotics only as prophylaxis within the context of Selective Di-gestive tract Decontamination (SDD)\n- Enrolment in another interventional trial\n- Patient received the study antibiotic for more than 24 hours before inclusion\n- Patient receiving extracorporeal membrane oxygenation (ECMO)\n- Patient is already treated with double dose of antibiotics based on suspected infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 28-day mortality","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- \t•\tBlood levels of antibiotics at 24, 48 and 72 hours after start therapy.","definition_or_measurement_approach":"Measured blood concentrations of study antibiotics at 24, 48 and 72 hours after start of therapy."}
- {"endpoint_text":"- \t•\tInfection parameters (CRP, procalcitonin, white blood cell count).","definition_or_measurement_approach":"Measurement of infection parameters: CRP, procalcitonin and white blood cell count."}
- {"endpoint_text":"- \t•\t365-day mortality","definition_or_measurement_approach":"Mortality assessed at 365 days after inclusion."}
- {"endpoint_text":"- \t•\t90-day mortality","definition_or_measurement_approach":"Mortality assessed at 90 days after inclusion."}
- {"endpoint_text":"- \t•\tHospital length of stay","definition_or_measurement_approach":"Duration of hospital stay measured in days."}
- {"endpoint_text":"- \t•\tICU length of stay","definition_or_measurement_approach":"Duration of ICU stay measured in days."}
- {"endpoint_text":"- Post study calculation of the costs in both study groups.","definition_or_measurement_approach":"Post hoc health economic calculation of treatment costs in both study groups."}
- {"endpoint_text":"- EQ5D questionnaire 3 and 12 months after admission","definition_or_measurement_approach":"Health-related quality of life measured by EQ-5D at 3 months and 12 months after admission."}
- {"endpoint_text":"- Number of AEs, SAEs and SUSARs","definition_or_measurement_approach":"Recording and counting adverse events (AEs), serious adverse events (SAEs) and SUSARs during the study period."}
- {"endpoint_text":"- Delta SOFA (T0- T3)","definition_or_measurement_approach":"Change in SOFA score from baseline (T0) to T3."}
Recruitment
- Planned Sample Size
- 988
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent must be given by the patient or a legal representative within three days after admittance (exclusion applies if not available). Subject information and informed consent forms are provided for adult patient and adult representative (documents L1_SIS and ICF adult representative; L1_SIS and ICF adult patient).
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 988
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 05-01-2026
- Processing Time Days
- 476
- Number Of Sites
- 18
- Number Of Participants
- 988
Sites
- Site Name
- Isala Klinieken Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Jasper Haringman
- Principal Investigator Email
- j.haringman@isala.nl
- Contact Person Name
- Jasper Haringman
- Contact Person Email
- j.haringman@isala.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Wouter de Ruijter
- Principal Investigator Email
- w.de.ruijter@nwz.nl
- Contact Person Name
- Wouter de Ruijter
- Contact Person Email
- w.de.ruijter@nwz.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- Intensive Care
- Principal Investigator Name
- Albert Beishuizen
- Principal Investigator Email
- ResearchIC@mst.nl
- Contact Person Name
- Albert Beishuizen
- Contact Person Email
- ResearchIC@mst.nl
- Site Name
- Het Van Weel-Bethesda Ziekenhuis
- Department Name
- Intensive Care
- Principal Investigator Name
- Fabienne van Aalst
- Principal Investigator Email
- aalstf@maasstadziekenhuis.nl
- Contact Person Name
- Fabienne van Aalst
- Contact Person Email
- aalstf@maasstadziekenhuis.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Intensive Care
- Principal Investigator Name
- Nicole Deetman
- Principal Investigator Email
- p.e.deetman@asz.nl
- Contact Person Name
- Nicole Deetman
- Contact Person Email
- p.e.deetman@asz.nl
- Site Name
- Haaglanden Medisch Centrum Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Peter van Vliet
- Principal Investigator Email
- p.van.vliet@haaglandenmc.nl
- Contact Person Name
- Peter van Vliet
- Contact Person Email
- p.van.vliet@haaglandenmc.nl
- Site Name
- Jeroen Bosch Ziekenhuis Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Florens Polderman
- Principal Investigator Email
- f.polderman@jbz.nl
- Contact Person Name
- Florens Polderman
- Contact Person Email
- f.polderman@jbz.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pharmacy
- Principal Investigator Name
- Nicole Hunfeld
- Principal Investigator Email
- n.hunfeld@erasmusmc.nl
- Contact Person Name
- Nicole Hunfeld
- Contact Person Email
- n.hunfeld@erasmusmc.nl
- Site Name
- Stichting Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Intensive Care
- Principal Investigator Name
- Chantal Boly
- Principal Investigator Email
- wetenschapsbureau@etz.nl
- Contact Person Name
- Chantal Boly
- Contact Person Email
- wetenschapsbureau@etz.nl
- Site Name
- Maasstad Ziekenhuis Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Corstiaan den Uil
- Principal Investigator Email
- uilc@maasstadziekenhuis.nl
- Contact Person Name
- Corstiaan den Uil
- Contact Person Email
- uilc@maasstadziekenhuis.nl
- Site Name
- Reinier de Graaf Groep
- Department Name
- Intensive Care
- Principal Investigator Name
- Rob Zwinkels
- Principal Investigator Email
- wetenschapsbureau@rdgg.nl
- Contact Person Name
- Rob Zwinkels
- Contact Person Email
- wetenschapsbureau@rdgg.nl
- Site Name
- IJsselland Ziekenhuis
- Department Name
- Intensive Care
- Principal Investigator Name
- Jan Elderman
- Principal Investigator Email
- dkehrer@ysl.nl
- Contact Person Name
- Jan Elderman
- Contact Person Email
- dkehrer@ysl.nl
- Site Name
- Amphia Hospital
- Department Name
- Intensive Care
- Principal Investigator Name
- Tom Rijpstra
- Principal Investigator Email
- trijpstra@amphia.nl
- Contact Person Name
- Tom Rijpstra
- Contact Person Email
- trijpstra@amphia.nl
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Marco Goeijenbier
- Principal Investigator Email
- WetenschapsBureau@spaarnegasthuis.nl
- Contact Person Name
- Marco Goeijenbier
- Contact Person Email
- WetenschapsBureau@spaarnegasthuis.nl
- Site Name
- Stichting OLVG
- Department Name
- Intensive Care
- Principal Investigator Name
- Hendrik Endeman
- Principal Investigator Email
- h.endeman@olvg.nl
- Contact Person Name
- Hendrik Endeman
- Contact Person Email
- h.endeman@olvg.nl
- Site Name
- Medisch Centrum Leeuwarden B.V.
- Department Name
- Intensive Care
- Principal Investigator Name
- Hanneke Buter
- Principal Investigator Email
- Wetenschap@mclacademie.nl
- Contact Person Name
- Hanneke Buter
- Contact Person Email
- Wetenschap@mclacademie.nl
- Site Name
- Ikazia Ziekenhuis
- Department Name
- Intensive Care
- Principal Investigator Name
- Susanne Stads
- Principal Investigator Email
- s.stads@ikazia.nl
- Contact Person Name
- Susanne Stads
- Contact Person Email
- s.stads@ikazia.nl
- Site Name
- Tergooiziekenhuizen
- Department Name
- Intensive Care
- Principal Investigator Name
- Carola van Ginkel
- Principal Investigator Email
- cvanginkel@tergooi.nl
- Contact Person Name
- Carola van Ginkel
- Contact Person Email
- cvanginkel@tergooi.nl
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
- Active Substance
- MEROPENEM TRIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 6 g
- Investigational Product Name
- Floxapen, poeder voor oplossing voor injectie 250 mg, 500 mg en 1 g
- Active Substance
- FLUCLOXACILLIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 12 g
- Investigational Product Name
- Cefotaxim 1000 mg PCH, poeder voor oplossing voor injectie
- Active Substance
- CEFOTAXIME
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 12 g
- Investigational Product Name
- Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
- Active Substance
- PIPERACILLIN SODIUM / TAZOBACTAM SODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 24 g
- Investigational Product Name
- Meropenem CF 1000 mg, poeder voor oplossing voor injectie of infusie
- Active Substance
- MEROPENEM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 6 g
- Investigational Product Name
- Cefuroxim Hikma 1500 mg poeder voor oplossing voor injectie of infusie
- Active Substance
- CEFUROXIME
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 9 g
- Investigational Product Name
- Amoxicilline/Clavulaanzuur Sandoz 2000 mg/200 mg i.v., poeder voor oplossing voor intraveneuze infusie
- Active Substance
- AMOXICILLIN / CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 8 g
- Investigational Product Name
- Ceftriaxon Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
- Active Substance
- CEFTRIAXONE SODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 4 g
- Investigational Product Name
- Ceftazidim Fresenius Kabi 500 mg poeder voor oplossing voor injectie
- Active Substance
- CEFTAZIDIME PENTAHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 12 g
- Investigational Product Name
- Amoxicilline CF (125/250/500/1000 mg) poeder voor oplossing voor injectie of infusie
- Active Substance
- AMOXICILLIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 12 g
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