Clinical trial • Phase III • Infectious Disease
VORICONAZOLE for Candidemia | Uncomplicated candidemia
Phase III trial of VORICONAZOLE for Candidemia | Uncomplicated candidemia.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Candidemia | Uncomplicated candidemia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-08-2025
- First CTIS Authorization Date
- 06-03-2026
Trial design
Randomised, open-label, standard duration arm: 14 days after the first negative blood culture using standard antifungal therapy (comparator antifungals listed include fluconazole, caspofungin, micafungin, anidulafungin, amphotericin b liposome, voriconazole). doses/schedules are not specified in the ctis extract.-controlled Phase III trial across 27 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard duration arm: 14 days after the first negative blood culture using standard antifungal therapy (comparator antifungals listed include fluconazole, caspofungin, micafungin, anidulafungin, amphotericin B liposome, voriconazole). Doses/schedules are not specified in the CTIS extract.
- Target Sample Size
- 399
- Trial Duration For Participant
- 45
Eligibility
Recruits 399 Vulnerable population not selected. Adults under legal guardianship are excluded. Written informed consent is required from the patient or his/her relatives (subject information and informed consent forms provided)..
- Pregnancy Exclusion
- Pregnancy, breastfeeding
- Vulnerable Population
- Vulnerable population not selected. Adults under legal guardianship are excluded. Written informed consent is required from the patient or his/her relatives (subject information and informed consent forms provided).
Inclusion criteria
- {"criterion_text":"- Adult (Age ≥ 18 years old) with a predicted life expectancy > 4 weeks"}
- {"criterion_text":"- With a positive Candida sp. blood culture allowing the diagnosis of candidemia"}
- {"criterion_text":"- Results of the 1st positive blood culture less than 72 hours at the time of inclusion"}
- {"criterion_text":"- If the patient is in aplasia (defined by neutrophil count below 500/mm3), predictive duration of aplasia must be less than 7 days"}
- {"criterion_text":"- Individual affiliated to a social security regimen"}
- {"criterion_text":"- Written informed consent from the patients or his/her relatives"}
Exclusion criteria
- {"criterion_text":"- Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment"}
- {"criterion_text":"- Candida strain resistant to the antifungal used"}
- {"criterion_text":"- Hypersensitivity or previous severe adverse drug reaction to the antifungal treatments"}
- {"criterion_text":"- Patient under legal guardianship"}
- {"criterion_text":"- Pregnancy, breastfeeding"}
- {"criterion_text":"- Women with childbearing age who has not used or does not plan to use acceptable birth control measures"}
- {"criterion_text":"- Unwilling, in the judgment of the investigator, to comply with the protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The Primary endpoint will be ACM at Day 28 (+/- 2 days) after the 1st negative blood for all randomized patients under antifungal treatment with a diagnosis of uncomplicated candidemia.","definition_or_measurement_approach":"All-cause mortality (ACM) assessed at Day 28 (+/-2 days) after the first negative blood culture for randomized patients with uncomplicated candidemia."}
Secondary endpoints
- {"endpoint_text":"- Proportion of randomized patients with secondary localizations","definition_or_measurement_approach":"Proportion of randomized patients who develop secondary localizations (timepoint not further specified in CTIS entry)."}
- {"endpoint_text":"- Cumulative incidence of death related to fungal infection at Day 28 (+/- 2 days) after the 1st negative blood culture","definition_or_measurement_approach":"Cumulative incidence of deaths attributable to candidemia assessed at Day 28 (+/-2 days) after the first negative blood culture."}
- {"endpoint_text":"- Liver function tests (ASAT, ALAT, GGT, PAL, bilirubin blood levels) according to the two treatment strategies at inclusion (Visit 1) randomization (Visit 2), at D14 (+/- 2 days) (Visit 3) (D1: day of the 1st drawn negative blood culture)","definition_or_measurement_approach":"Clinical and biological hepatic tolerance assessed by ASAT, ALAT, GGT, PAL and bilirubin at inclusion, at randomization, and at Day 14 (+/-2 days) (D1 = day of the first negative blood culture)."}
- {"endpoint_text":"- Incremental cost effectiveness ratio: cost per extra-day alive without antifungal treatment up to D28 (+/- 2 days) (Visit 4) if patients still hospitalized","definition_or_measurement_approach":"Health economic endpoint: incremental cost-effectiveness ratio measured as cost per extra-day alive without antifungal treatment up to Day 28 (+/-2 days) (for patients still hospitalized)."}
- {"endpoint_text":"- Proportion of randomized patients with relapse at D45 (+/- 2 days)","definition_or_measurement_approach":"Proportion of randomized patients experiencing relapse assessed at Day 45 (+/-2 days)."}
- {"endpoint_text":"- Proportion of randomized patients with secondary localization at D45 (+/- 2 days)","definition_or_measurement_approach":"Proportion of randomized patients with secondary localization assessed at Day 45 (+/-2 days)."}
Recruitment
- Planned Sample Size
- 399
- Recruitment Window Months
- 26
- Consent Approach
- Written informed consent from the patient or his/her relatives is required (subject information and informed consent forms available: L1_SIS-ICF_majeur and related documents). No paediatric/assent procedures described; consent appears to be adult-focused.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 399
France
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 140
- Number Of Sites
- 27
- Number Of Participants
- 399
Sites
- Site Name
- Centre Hospitalier De Perpignan
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Alexis REDOR
- Principal Investigator Email
- Alexis.redor@ch-perpignan.fr
- Contact Person Name
- Alexis REDOR
- Contact Person Email
- Alexis.redor@ch-perpignan.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service de Médecine Intensive et Réanimation
- Principal Investigator Name
- Saad NSEIR
- Principal Investigator Email
- saadalla.nseir@chru-lille.fr
- Contact Person Name
- Saad NSEIR
- Contact Person Email
- saadalla.nseir@chru-lille.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Services des Maladies Infectieuses
- Principal Investigator Name
- Pierre BERGER
- Principal Investigator Email
- bergerp@ipc.unicancer.fr
- Contact Person Name
- Pierre BERGER
- Contact Person Email
- bergerp@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Sud Francilien
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Amélie CHABROL
- Principal Investigator Email
- amelie.chabrol@chsf.fr
- Contact Person Name
- Amélie CHABROL
- Contact Person Email
- amelie.chabrol@chsf.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Equipe Mobile d'Infectiologie
- Principal Investigator Name
- Caroline CHARLIER
- Principal Investigator Email
- caroline.charlier@aphp.fr
- Contact Person Name
- Caroline CHARLIER
- Contact Person Email
- caroline.charlier@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Fanny LANTERNIER
- Principal Investigator Email
- fanny.lanternier@aphp.fr
- Contact Person Name
- Fanny LANTERNIER
- Contact Person Email
- fanny.lanternier@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Blandine DENIS
- Principal Investigator Email
- blandine.denis@ahp.fr
- Contact Person Name
- Blandine DENIS
- Contact Person Email
- blandine.denis@ahp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Unité Transversale de Traitement des Infections (Département de Prévention Diagnostic et Traitement)
- Principal Investigator Name
- Raphaël LEPEULE
- Principal Investigator Email
- raphael.lepeule@aphp.fr
- Contact Person Name
- Raphaël LEPEULE
- Contact Person Email
- raphael.lepeule@aphp.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service des Maladies Infectieuses et Tropicales et Médecine Interne
- Principal Investigator Name
- Francois DANION
- Principal Investigator Email
- francois.danion@chru-strasbourg.fr
- Contact Person Name
- Francois DANION
- Contact Person Email
- francois.danion@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Chirurgie Générale et Digestive
- Principal Investigator Name
- Thibault VORON
- Principal Investigator Email
- thibault.voron@aphp.fr
- Contact Person Name
- Thibault VORON
- Contact Person Email
- thibault.voron@aphp.fr
- Site Name
- Fondation Hopital Saint Joseph
- Department Name
- Département de Microbiologie
- Principal Investigator Name
- Benoît PILMIS
- Principal Investigator Email
- bpilmis@ghpsj.fr
- Contact Person Name
- Benoît PILMIS
- Contact Person Email
- bpilmis@ghpsj.fr
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Service de Réanimation / Unité de Surveillance Continue
- Principal Investigator Name
- Fabrice BRUNEEL
- Principal Investigator Email
- fbruneel@ch-versailles.fr
- Contact Person Name
- Fabrice BRUNEEL
- Contact Person Email
- fbruneel@ch-versailles.fr
- Site Name
- Centre Hospitalier Victor Dupouy
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Marie DUBERT
- Principal Investigator Email
- Marie.dubert@ch-argenteuil.fr
- Contact Person Name
- Marie DUBERT
- Contact Person Email
- Marie.dubert@ch-argenteuil.fr
- Site Name
- Hospital Foch
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Marie-Alice COLOMBIER
- Principal Investigator Email
- ma.colombier@hopital-foch.com
- Contact Person Name
- Marie-Alice COLOMBIER
- Contact Person Email
- ma.colombier@hopital-foch.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Services des Maladies Infectieuses
- Principal Investigator Name
- Lelia ESCAUT
- Principal Investigator Email
- lelia.escaut@aphp.fr
- Contact Person Name
- Lelia ESCAUT
- Contact Person Email
- lelia.escaut@aphp.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- Service Universitaire des Maladies Infectieuses et du Voyageur
- Principal Investigator Name
- Serge ALFANDARI
- Principal Investigator Email
- salfandari@ch-tourcoing.fr
- Contact Person Name
- Serge ALFANDARI
- Contact Person Email
- salfandari@ch-tourcoing.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service de Médecine Interne et de Maladies Infectieuses
- Principal Investigator Name
- Nahema ISSA
- Principal Investigator Email
- nahema.issa@chu-bordeaux.fr
- Contact Person Name
- Nahema ISSA
- Contact Person Email
- nahema.issa@chu-bordeaux.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Florence ADER
- Principal Investigator Email
- florence.ader@chu-lyon.fr
- Contact Person Name
- Florence ADER
- Contact Person Email
- florence.ader@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Services des Maladies Infectieuses
- Principal Investigator Name
- Mathieu BLOT
- Principal Investigator Email
- mathieu.blot@chu-dijon.fr
- Contact Person Name
- Mathieu BLOT
- Contact Person Email
- mathieu.blot@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Benjamin GABORIT
- Principal Investigator Email
- benjamin.gaborit@chu-nantes.fr
- Contact Person Name
- Benjamin GABORIT
- Contact Person Email
- benjamin.gaborit@chu-nantes.fr
- Site Name
- Institut Mutualiste Montsouris
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Marine De LAROCHE
- Principal Investigator Email
- marine.delaroche@imm.fr
- Contact Person Name
- Marine De LAROCHE
- Contact Person Email
- marine.delaroche@imm.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Guillaume MARTIN-BLONDEL
- Principal Investigator Email
- Martin-blondel.g@chu-toulouse.fr
- Contact Person Name
- Guillaume MARTIN-BLONDEL
- Contact Person Email
- Martin-blondel.g@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service de Maladies Infectieuses et Tropicales et Réanimation Médicale
- Principal Investigator Name
- Matthieu REVEST
- Principal Investigator Email
- matthieu.revest@chu-rennes.fr
- Contact Person Name
- Matthieu REVEST
- Contact Person Email
- matthieu.revest@chu-rennes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Agnès LEFORT
- Principal Investigator Email
- agnes.lefort@aphp.fr
- Contact Person Name
- Agnès LEFORT
- Contact Person Email
- agnes.lefort@aphp.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Valérie GARRAIT
- Principal Investigator Email
- valerie.garrait@chicreteil.fr
- Contact Person Name
- Valérie GARRAIT
- Contact Person Email
- valerie.garrait@chicreteil.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Service de Réanimation (Département DIOPP)
- Principal Investigator Name
- Annabelle STOCLIN
- Principal Investigator Email
- Annabelle.stoclin@gustaveroussy.fr
- Contact Person Name
- Annabelle STOCLIN
- Contact Person Email
- Annabelle.stoclin@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses
- Principal Investigator Name
- Alexandre BLEIBTREU
- Principal Investigator Email
- alexandre.bleibtreu@aphp.fr
- Contact Person Name
- Alexandre BLEIBTREU
- Contact Person Email
- alexandre.bleibtreu@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- VORICONAZOLE
- Active Substance
- VORICONAZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Maximum Dose
- Max daily dose: 12 mg/kg; Max total dose: 60 mg/kg; Max treatment period: 7 days
- Investigational Product Name
- ANIDULAFUNGIN
- Active Substance
- ANIDULAFUNGIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- Max daily dose: 200 mg; Max total dose: 800 mg; Max treatment period: 7 days
- Investigational Product Name
- CASPOFUNGIN
- Active Substance
- CASPOFUNGIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- Max daily dose: 70 mg; Max total dose: 370 mg; Max treatment period: 7 days
- Investigational Product Name
- AMPHOTERICINE B, LIPOSOME
- Active Substance
- AMPHOTERICINE B, LIPOSOME
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- Max daily dose: 5 mg/kg; Max total dose: 35 mg/kg; Max treatment period: 7 days
- Investigational Product Name
- FLUCONAZOLE
- Active Substance
- FLUCONAZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- Max daily dose: 12 mg/kg; Max total dose: 48 mg (one entry) / 90 mg (other entry) depending on formulation; Max treatment period: 7-14 days
- Investigational Product Name
- MICAFUNGIN
- Active Substance
- MICAFUNGIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- Max daily dose: 100 mg; Max total dose: 700-1400 mg depending on formulation; Max treatment period: 7-14 days
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