Clinical trial • Not applicable • Gastroenterology
ERTAPENEM for Acute cholecystitis
Not applicable trial of ERTAPENEM for Acute cholecystitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Acute cholecystitis
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-09-2024
- First CTIS Authorization Date
- 07-04-2025
Trial design
Randomised, open-label, single-dose antibiotics preoperatively versus continuous antibiotics preoperatively; specific drug, dose and schedule not specified in the provided data.-controlled Not applicable trial across 3 sites in Finland.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Single-dose antibiotics preoperatively versus continuous antibiotics preoperatively; specific drug, dose and schedule not specified in the provided data.
- Target Sample Size
- 456
- Trial Duration For Participant
- 30
Eligibility
Recruits 456 Subjects with reduced capacity for self-determination are excluded; the trial indicates isVulnerablePopulationSelected:false. Subject information and informed consent forms are listed in the trial documents..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Subjects with reduced capacity for self-determination are excluded; the trial indicates isVulnerablePopulationSelected:false. Subject information and informed consent forms are listed in the trial documents.
Inclusion criteria
- {"criterion_text":"- Patients with diagnosed mild or moderate acute cholecystitis (according to Tokyo Guidelines)"}
Exclusion criteria
- {"criterion_text":"- Age under 18 years"}
- {"criterion_text":"- Class D drug-drug interactions"}
- {"criterion_text":"- Tokyo Guidelines Grade III cholecystitis (see protocol)"}
- {"criterion_text":"- subjects with reduced capacity for self-determination"}
- {"criterion_text":"- Pregnancy"}
- {"criterion_text":"- Peritonitis"}
- {"criterion_text":"- Suspicion of cholangitis (Charcot's triad or radiologic findings)"}
- {"criterion_text":"- Bile duct stones"}
- {"criterion_text":"- Allergy to all antibiotics in protocol"}
- {"criterion_text":"- Antibiotics 24 hours prior to randomisation"}
- {"criterion_text":"- Breastfeeding women"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The rate of postoperative infectious complications within 30 days from randomisation","definition_or_measurement_approach":"Rate of postoperative infectious complications assessed within 30 days from randomisation"}
Secondary endpoints
- {"endpoint_text":"- The conversion rate from laparoscopic to open cholecystectomy during the primary operation","definition_or_measurement_approach":"Conversion rate during the primary operation"}
- {"endpoint_text":"- The Comprehensive Complication Index according to the Clavien-Dindo Classification within 30 days postoperatively","definition_or_measurement_approach":"Comprehensive Complication Index measured according to the Clavien-Dindo Classification within 30 days postoperatively"}
- {"endpoint_text":"- A composite outcome incorporating the rate of all antibiotic-related adverse outcomes (hypersensitivity reactions, clostridium difficile diarrhea, yeast infections) within 30 days postoperatively","definition_or_measurement_approach":"Composite outcome: rate of listed antibiotic-related adverse outcomes measured within 30 days postoperatively"}
- {"endpoint_text":"- The length of stay","definition_or_measurement_approach":"Length of hospital stay (definition/schedule not further specified in provided data)"}
Recruitment
- Planned Sample Size
- 456
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent is required from participants; participants under 18 are excluded. Subject information and informed consent form documents are listed in the trial documents (multiple versions available).
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 456
Finland
- Earliest CTIS Part Ii Submission Date
- 07-03-2025
- Latest Decision Or Authorization Date
- 09-04-2025
- Processing Time Days
- 33
- Number Of Sites
- 3
- Number Of Participants
- 456
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Jorvi Hospital
- Principal Investigator Name
- Hanna Lampela
- Principal Investigator Email
- hanna.lampela@hus.fi
- Contact Person Name
- Hanna Lampela
- Contact Person Email
- hanna.lampela@hus.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Hyvinkää Hospital
- Principal Investigator Name
- Hanna Koppatz
- Principal Investigator Email
- hanna.koppatz@hus.fi
- Contact Person Name
- Hanna Koppatz
- Contact Person Email
- hanna.koppatz@hus.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Meilahti Hospital
- Principal Investigator Name
- Panu Mentula
- Principal Investigator Email
- panu.mentula@hus.fi
- Contact Person Name
- Panu Mentula
- Contact Person Email
- panu.mentula@hus.fi
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- INVANZ 1 g powder for concentrate for solution for infusion
- Active Substance
- ERTAPENEM
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos
- Active Substance
- CIPROFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised
- Investigational Product Name
- Cefuroxime Orion Pharma 1,5 g injektio/infuusiokuiva-aine, liuosta/suspensiota varten
- Active Substance
- CEFUROXIME
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised
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