Clinical trial • Phase III • Infectious Disease
CASPOFUNGIN for Intra-abdominal candidiasis (yeast intra-abdominal infection) | Peritonitis
Phase III trial of CASPOFUNGIN for Intra-abdominal candidiasis (yeast intra-abdominal infection) | Peritonitis.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Intra-abdominal candidiasis (yeast intra-abdominal infection) | Peritonitis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme | Small molecule
Key dates
- Initial CTIS Submission Date
- 29-07-2024
- First CTIS Authorization Date
- 13-08-2024
Trial design
Randomised, caspofungin (cancidas; intravenous infusion; treatment duration 8 days; available presentations referenced: 50 mg and 70 mg) vs placebo (sodium chloride 0.9% intravenous infusion for 8 days).-controlled Phase III trial across 22 sites in France.
- Randomised
- Yes
- Comparator
- Caspofungin (CANCIDAS; intravenous infusion; treatment duration 8 days; available presentations referenced: 50 mg and 70 mg) vs Placebo (Sodium Chloride 0.9% intravenous infusion for 8 days).
- Target Sample Size
- 448
- Trial Duration For Participant
- 90
Eligibility
Recruits 448 isVulnerablePopulationSelected true; consent must be 'With written and signed informed consent' (patient or representative). Subject information and informed consent forms for patient, representative, emergency and trusted person/close relative are provided in the documentation..
- Pregnancy Exclusion
- Pregnant or lactating women
- Vulnerable Population
- isVulnerablePopulationSelected true; consent must be 'With written and signed informed consent' (patient or representative). Subject information and informed consent forms for patient, representative, emergency and trusted person/close relative are provided in the documentation.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years old"}
- {"criterion_text":"- Covered by national health insurance"}
- {"criterion_text":"- Admitted to ICU after surgery for intra-abdominal infection : - With suspected intra-abdominal candidiasis defined by a Peritonitis score ≥ 3 - Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively"}
- {"criterion_text":"- With written and signed informed consent"}
Exclusion criteria
- {"criterion_text":"- Allergy to caspofungin"}
- {"criterion_text":"- Life expectancy ≤ 48h"}
- {"criterion_text":"- Expected withdrawal of treatment"}
- {"criterion_text":"- Radiological drainage without surgery"}
- {"criterion_text":"- Severe hepatic impairment (Child-Pugh C score)"}
- {"criterion_text":"- Pregnant or lactating women"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 28-day failure rate after the beginning of treatment","definition_or_measurement_approach":"Failure rate measured at 28 days after treatment start in the intention-to-treat (ITT) analysis (main objective: Decrease of failure rate at 28-day after the beginning of treatment in ITT analysis)."}
Secondary endpoints
- {"endpoint_text":"- 28 and 90-day mortality","definition_or_measurement_approach":"Crude mortality measured at 28 days and 90 days on ITT and PP analysis."}
- {"endpoint_text":"- Success rate at the end of treatment","definition_or_measurement_approach":"Success rate assessed at end of treatment on ITT and PP analysis."}
- {"endpoint_text":"- Slope of ß-D-glucan concentrations","definition_or_measurement_approach":"Change (slope) of serum ß-D-glucan concentrations over time, including measurement at end of treatment."}
- {"endpoint_text":"- 28-day mortality for subgroup analysis","definition_or_measurement_approach":"28-day mortality evaluated in predefined subgroups (community-acquired vs healthcare-associated, timing of antifungal therapy, C. albicans vs non-albicans, septic shock vs no shock)."}
Recruitment
- Planned Sample Size
- 448
- Recruitment Window Months
- 75
- Consent Approach
- Written and signed informed consent required from the patient or from a representative. Documentation includes subject information and ICF forms for patient, subsequent patient, representative, representative subsequent, emergency and trusted person/close relative. Documents available (titles) indicate French-language materials and provisions for representative/emergency consent.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 448
France
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 02-12-2025
- Processing Time Days
- 487
- Number Of Sites
- 22
- Number Of Participants
- 448
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- ICU
- Principal Investigator Name
- Hervé DUPONT
- Principal Investigator Email
- dupont.herve@chu-amiens.fr
- Contact Person Name
- Hervé DUPONT
- Contact Person Email
- dupont.herve@chu-amiens.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Creteil)
- Department Name
- ICU
- Principal Investigator Name
- Quentin DE ROUX
- Principal Investigator Email
- quentin.deroux@aphp.fr
- Contact Person Name
- Quentin DE ROUX
- Contact Person Email
- quentin.deroux@aphp.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- ICU
- Principal Investigator Name
- Julien POTTECHER
- Principal Investigator Email
- julien.pottecher@chru-strasbourg.fr
- Contact Person Name
- Julien POTTECHER
- Contact Person Email
- julien.pottecher@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Clichy)
- Department Name
- ICU
- Principal Investigator Name
- Marina HACHOUF
- Principal Investigator Email
- marina.hachouf@aphp.fr
- Contact Person Name
- Marina HACHOUF
- Contact Person Email
- marina.hachouf@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Paris Cedex 10)
- Department Name
- ICU
- Principal Investigator Name
- Emmanuel DUDOIGNON
- Principal Investigator Email
- emmanuel.dudoignon@aphp.fr
- Contact Person Name
- Emmanuel DUDOIGNON
- Contact Person Email
- emmanuel.dudoignon@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- ICU
- Principal Investigator Name
- Yoann LAUNEY
- Principal Investigator Email
- yoann.launey@chu-rennes.fr
- Contact Person Name
- Yoann LAUNEY
- Contact Person Email
- yoann.launey@chu-rennes.fr
- Site Name
- CHRU De Nancy
- Department Name
- ICU
- Principal Investigator Name
- Emmanuel NOVY
- Principal Investigator Email
- e.novy@chru-nancy.fr
- Contact Person Name
- Emmanuel NOVY
- Contact Person Email
- e.novy@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- ICU
- Principal Investigator Name
- Philippe GOUIN
- Principal Investigator Email
- Philippe.Gouin@chu-rouen.fr
- Contact Person Name
- Philippe GOUIN
- Contact Person Email
- Philippe.Gouin@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- ICU
- Principal Investigator Name
- Jean-Yves LEFRANT
- Principal Investigator Email
- jean.yves.lefrant@chu-nimes.fr
- Contact Person Name
- Jean-Yves LEFRANT
- Contact Person Email
- jean.yves.lefrant@chu-nimes.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- ICU
- Principal Investigator Name
- Claire DAHYOT-FIZELIER
- Principal Investigator Email
- claire.dahyot-fizelier@chu-poitiers.fr
- Contact Person Name
- Claire DAHYOT-FIZELIER
- Contact Person Email
- claire.dahyot-fizelier@chu-poitiers.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Paris Cedex 18)
- Department Name
- ICU
- Principal Investigator Name
- Philippe MONTRAVERS
- Principal Investigator Email
- philippe.montravers@aphp.fr
- Contact Person Name
- Philippe MONTRAVERS
- Contact Person Email
- philippe.montravers@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- ICU
- Principal Investigator Name
- Yannick HOURMANT
- Principal Investigator Email
- yannick.hourmant@chu-nantes.fr
- Contact Person Name
- Yannick HOURMANT
- Contact Person Email
- yannick.hourmant@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- ICU
- Principal Investigator Name
- Serge MOLLIEX
- Principal Investigator Email
- serge.molliex@chu-st-etienne.fr
- Contact Person Name
- Serge MOLLIEX
- Contact Person Email
- serge.molliex@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- ICU
- Principal Investigator Name
- Bélaid BOUHEMAD
- Principal Investigator Email
- belaid.bouhemad@chu-dijon.fr
- Contact Person Name
- Bélaid BOUHEMAD
- Contact Person Email
- belaid.bouhemad@chu-dijon.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- ICU
- Principal Investigator Name
- Virginie LAURENT
- Principal Investigator Email
- vlaurent@ght78sud.fr
- Contact Person Name
- Virginie LAURENT
- Contact Person Email
- vlaurent@ght78sud.fr
- Site Name
- CH Argenteuil
- Department Name
- ICU
- Principal Investigator Name
- Gaétan PLANTEFEVE
- Principal Investigator Email
- gaetan.plantefeve@ch-argenteuil.fr
- Contact Person Name
- Gaétan PLANTEFEVE
- Contact Person Email
- gaetan.plantefeve@ch-argenteuil.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- ICU
- Principal Investigator Name
- Antoine DEWITTE
- Principal Investigator Email
- antoine.dewitte@chu-bordeaux.fr
- Contact Person Name
- Antoine DEWITTE
- Contact Person Email
- antoine.dewitte@chu-bordeaux.fr
- Site Name
- CHU Besancon
- Department Name
- ICU
- Principal Investigator Name
- Sébastien PILI-FLOURY
- Principal Investigator Email
- spilifloury@chu-besancon.fr
- Contact Person Name
- Sébastien PILI-FLOURY
- Contact Person Email
- spilifloury@chu-besancon.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Paris)
- Department Name
- ICU
- Principal Investigator Name
- Natacha KAPANDJI
- Principal Investigator Email
- natacha.kapandji@aphp.fr
- Contact Person Name
- Natacha KAPANDJI
- Contact Person Email
- natacha.kapandji@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- ICU
- Principal Investigator Name
- Fabrice THIOLLIERE
- Principal Investigator Email
- fabrice.thiolliere01@chu-lyon.fr
- Contact Person Name
- Fabrice THIOLLIERE
- Contact Person Email
- fabrice.thiolliere01@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Paris Cedex 13)
- Department Name
- ICU
- Principal Investigator Name
- Antoine MONSEL
- Principal Investigator Email
- antoine.monsel@aphp.fr
- Contact Person Name
- Antoine MONSEL
- Contact Person Email
- antoine.monsel@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- ICU
- Principal Investigator Name
- Eric KIPNIS
- Principal Investigator Email
- eric.kipnis@chru-lille.fr
- Contact Person Name
- Eric KIPNIS
- Contact Person Email
- eric.kipnis@chru-lille.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- CANCIDAS 50 mg powder for concentrate for solution for infusion
- Active Substance
- CASPOFUNGIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/01/196/001)
- Dose Levels
- 50 mg
- Frequency
- Daily
- Maximum Dose
- 50 mg (maxDailyDoseAmount); maxTotalDoseAmount 420 mg
- Investigational Product Name
- CANCIDAS 70 mg powder for concentrate for solution for infusion
- Active Substance
- CASPOFUNGIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/01/196/003)
- Dose Levels
- 70 mg
- Frequency
- Daily
- Maximum Dose
- 70 mg (maxDailyDoseAmount); maxTotalDoseAmount 560 mg
- Investigational Product Name
- Sodium Chloride B Braun 0,9% süstelahus
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation 271899)
- Dose Levels
- 0.9%
- Maximum Dose
- 0.9%
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