Clinical trial • Phase IV • Infectious Disease
FLUCONAZOLE for Fungal infection
Phase IV trial of FLUCONAZOLE for Fungal infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Fungal infection
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-11-2023
- First CTIS Authorization Date
- 16-02-2024
Trial design
Randomised, placebo (natriumklorid "b. braun" intravenous infusion) versus fluconazole kabi 2mg/ml solution for infusion (fluconazole). ctis record provides product entries including max daily dose for fluconazole (400 mg) and max treatment period (30 days) but specific dosing schedule in the protocol is not provided in the ctis json.-controlled Phase IV trial across 5 sites in Denmark.
- Randomised
- Yes
- Comparator
- Placebo (Natriumklorid "B. Braun" intravenous infusion) versus Fluconazole Kabi 2mg/ml solution for infusion (fluconazole). CTIS record provides product entries including max daily dose for fluconazole (400 mg) and max treatment period (30 days) but specific dosing schedule in the protocol is not provided in the CTIS JSON.
- Target Sample Size
- 420
- Trial Duration For Participant
- 90
Eligibility
Recruits 420 No vulnerable population selected. Participants must be able to understand and sign informed consent in Danish (inclusion criterion requires ability to understand and sign an informed consent in Danish)..
- Vulnerable Population
- No vulnerable population selected. Participants must be able to understand and sign informed consent in Danish (inclusion criterion requires ability to understand and sign an informed consent in Danish).
Inclusion criteria
- {"criterion_text":"- Patients > 18 years\n- Willingness to participate in the study and the ability to understand and sign an informed consent in Danish\n- Indication for performing cystectomy\n- The urinary diversion is limited to the ileal conduit"}
Exclusion criteria
- {"criterion_text":"- Patients with contraindications to Fluconazole. This includes allergies and treatment with non-pausable medication that in combination is contraindicated\n- Patients in active treatment for mycotic infections"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Postoperative complications measured by Clavien Dindo III-V classification score","definition_or_measurement_approach":"Measured by Clavien Dindo III-V classification score (as stated)"}
Secondary endpoints
- {"endpoint_text":"- Days Alive and Out of Hospital measured within the 90th postoperative day","definition_or_measurement_approach":"Measured as days alive and out of hospital within the 90th postoperative day (as stated)"}
- {"endpoint_text":"- Time to gastrointestinal function (first bowel movement) postoperatively","definition_or_measurement_approach":"Measured as time to first bowel movement postoperatively (as stated)"}
- {"endpoint_text":"- Reduction in percentage of patients who require placement of nasogastric tube postoperatively","definition_or_measurement_approach":"Measured as percentage of patients requiring nasogastric tube placement postoperatively (as stated)"}
- {"endpoint_text":"- Quality of Life measured by questionnaires (EORTC QLQ-C30 and QLQ-BLM30) at day 0 and day 90","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 and QLQ-BLM30 questionnaires at baseline (day 0) and day 90 (as stated)"}
- {"endpoint_text":"- Length of stay for index admission","definition_or_measurement_approach":"Measured as length of stay for the index admission (as stated)"}
- {"endpoint_text":"- Re-admission within 30 and 90 days","definition_or_measurement_approach":"Measured as readmission rates within 30 days and 90 days postoperatively (as stated)"}
- {"endpoint_text":"- Microbiome resistance development in the urinary tract","definition_or_measurement_approach":"Measured as development of microbiome resistance in the urinary tract (as stated)"}
- {"endpoint_text":"- Urinary tract infections requiring treatment","definition_or_measurement_approach":"Measured as occurrence of urinary tract infections that require treatment (as stated)"}
Recruitment
- Planned Sample Size
- 420
- Recruitment Window Months
- 30
- Consent Approach
- Participants must be able to understand and sign an informed consent in Danish. Inclusion criterion requires willingness to participate and ability to understand and sign informed consent in Danish. Subject information and informed consent form documents are listed in the CTIS record (titles include 'Deltagerinformation' and 'Participant information'). No assent process is required because participants must be >18 years.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 420
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-02-2024
- Latest Decision Or Authorization Date
- 16-09-2025
- Processing Time Days
- 578
- Number Of Sites
- 5
- Number Of Participants
- 420
Sites
- Site Name
- Herlev Hospital
- Department Name
- Department of Urology
- Contact Person Name
- Ann Bersang
- Contact Person Email
- ann.kortbaek.bersang@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Urology
- Contact Person Name
- Lars Lund
- Contact Person Email
- lars.lund@rsyd.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Urology
- Contact Person Name
- Knud Fabrin
- Contact Person Email
- knf@rn.dk
- Site Name
- Aarhus Universitet
- Department Name
- Department of Urology
- Contact Person Name
- Pernille Skjold Kingo
- Contact Person Email
- perkin@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Urology
- Contact Person Name
- Andreas Røder
- Contact Person Email
- andreas.roeder@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Rigshospitalet
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Fluconazole Kabi 2mg/ml solution for infusion
- Active Substance
- FLUCONAZOLE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised (marketing authorisation number MA1123/00802 listed)
- Maximum Dose
- Max daily dose 400 mg; max total dose amount 12000 mg (as reported in CTIS product entry)
- Investigational Product Name
- Natriumklorid "B. Braun"
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised (marketing authorisation number 13341 listed)
- Maximum Dose
- Max daily dose 6 (unit: mmol/kg per CTIS entry); max total dose amount 10000 ml (as reported in CTIS product entry)
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