Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
399
Countries
1
Sites
27
Uncomplicated candidemia
To demonstrate that, in uncomplicated candidemia, a duration of treatment of 7 days after the first negative blood culture is non-inferior to a duration of 14 days after the first negative blood culture for all-cause mortality (ACM) at Day 28 (+/- 2 days).
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2026-03-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514244-81-00
- ClinicalTrials.gov
- NCT06859671
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacoeconomic, Safety, Therapy
To demonstrate that, in uncomplicated candidemia, a duration of treatment of 7 days after the first negative blood culture is non-inferior to a duration of 14 days after the first negative blood culture for all-cause mortality (ACM) at Day 28 (+/- 2 days).
Secondary objectives 6
- To study the clinical efficacy in both groups and in particular the absence of secondary localization of candidemia
- To study the incidence of deaths attributable to candidemia up to D28 (+/- 2 days) after the 1st negative blood culture
- To study the clinical and biological hepatic tolerance until D14 (+/- 2 days) after the 1st negative blood culture
- To estimate the cost effectiveness of the shortened duration of treatment compared to the standard duration of treatment for all randomized patients
- To study the absence of relapse at D45 (+/- 2 days)
- To study the absence of secondary localization of candidemia at D45 (+/- 2 days)
Conditions and MedDRA coding
Uncomplicated candidemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10060573 | Candidemia | 10021881 |
| 20.0 | HLT | 10007134 | Candida infections | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Adult (Age ≥ 18 years old) with a predicted life expectancy > 4 weeks
- With a positive Candida sp. blood culture allowing the diagnosis of candidemia
- Results of the 1st positive blood culture less than 72 hours at the time of inclusion
- If the patient is in aplasia (defined by neutrophil count below 500/mm3), predictive duration of aplasia must be less than 7 days
- Individual affiliated to a social security regimen
- Written informed consent from the patients or his/her relatives
Exclusion criteria 7
- 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
- Candida strain resistant to the antifungal used
- Hypersensitivity or previous severe adverse drug reaction to the antifungal treatments
- Patient under legal guardianship
- Pregnancy, breastfeeding
- Women with childbearing age who has not used or does not plan to use acceptable birth control measures
- Unwilling, in the judgment of the investigator, to comply with the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 6
- Proportion of randomized patients with secondary localizations
- Cumulative incidence of death related to fungal infection at Day 28 (+/- 2 days) after the 1st negative blood culture
- 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)
- Incremental cost effectiveness ratio: cost per extra-day alive without antifungal treatment up to D28 (+/- 2 days) (Visit 4) if patients still hospitalized
- Proportion of randomized patients with relapse at D45 (+/- 2 days)
- Proportion of randomized patients with secondary localization at D45 (+/- 2 days)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SUB12887MIG · Substance
- Active substance
- Amphotericine B, Liposome
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 35 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB22240 · Substance
- Active substance
- Anidulafungin
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16405MIG · Substance
- Active substance
- Caspofungin
- Pharmaceutical form
- POWDER FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 70 mg milligram(s)
- Max total dose
- 370 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07674MIG · Substance
- Active substance
- Fluconazole
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 12 mg/kg milligram(s)/kilogram
- Max total dose
- 48 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16444MIG · Substance
- Active substance
- Micafungin
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 700 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00087MIG · Substance
- Active substance
- Voriconazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 12 mg/kg milligram(s)/kilogram
- Max total dose
- 60 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 6
SUB22240 · Substance
- Active substance
- Anidulafungin
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00087MIG · Substance
- Active substance
- Voriconazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 12 mg/kg milligram(s)/kilogram
- Max total dose
- 116 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16444MIG · Substance
- Active substance
- Micafungin
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1400 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07674MIG · Substance
- Active substance
- Fluconazole
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 12 mg/kg milligram(s)/kilogram
- Max total dose
- 90 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16405MIG · Substance
- Active substance
- Caspofungin
- Pharmaceutical form
- POWDER FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 70 mg milligram(s)
- Max total dose
- 720 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12887MIG · Substance
- Active substance
- Amphotericine B, Liposome
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 70 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Blandine Denis (Coordinating investigator)
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Blandine Denis (Coordinating investigator)
Locations
1 EU/EEA country · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 399 | 27 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Sud Francilien
Service des Maladies Infectieuses et Tropicales, 40 Avenue Serge Dassault, 91106, Corbeil Essonnes Cedex
Institut Paoli Calmettes
Services des Maladies Infectieuses, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Assistance Publique Hopitaux De Paris
Service des Maladies Infectieuses et Tropicales, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier De Perpignan
Service des Maladies Infectieuses et Tropicales, 20 Avenue Du Languedoc, Cs 49954, Perpignan Cedex
Assistance Publique Hopitaux De Paris
Service de Chirurgie Générale et Digestive, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Universitaire De Nantes
Service des Maladies Infectieuses et Tropicales, 1 Place Alexis Ricordeau, 44000, Nantes
Les Hopitaux Universitaires De Strasbourg
Service des Maladies Infectieuses et Tropicales et Médecine Interne, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Dijon
Services des Maladies Infectieuses, 14 Rue Paul Gaffarel, 21000, Dijon
Hospices Civils De Lyon
Service des Maladies Infectieuses et Tropicales, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Assistance Publique Hopitaux De Paris
Unité Transversale de Traitement des Infections (Département de Prévention Diagnostic et Traitement), 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Institut Mutualiste Montsouris
Service de Médecine Interne, 42 Boulevard Jourdan, 75014, Paris
Centre Hospitalier Victor Dupouy
Service des Maladies Infectieuses et Tropicales, 69 Rue Du Lieutenant Colonel Prudhon, 95107, Argenteuil Cedex
Centre Hospitalier Universitaire De Bordeaux
Service de Médecine Interne et de Maladies Infectieuses, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Hospital Foch
Service de Médecine Interne, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier Universitaire De Rennes
Service de Maladies Infectieuses et Tropicales et Réanimation Médicale, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier De Tourcoing
Service Universitaire des Maladies Infectieuses et du Voyageur, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier Universitaire De Toulouse
Service des Maladies Infectieuses et Tropicales, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Centre Hospitalier De Versailles
Service de Réanimation / Unité de Surveillance Continue, 177 Rue De Versailles, Le Chesnay, Le Chesnay Rocquencourt
Centre Hospitalier Universitaire De Lille
Service de Médecine Intensive et Réanimation, Rue Emile Laine, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Service des Maladies Infectieuses, 43 Boulevard De L Hopital, 75013, Paris
Fondation Hopital Saint Joseph
Département de Microbiologie, 185 Rue Raymond Losserand, 75014, Paris
Assistance Publique Hopitaux De Paris
Equipe Mobile d'Infectiologie, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Intercommunal Creteil
Service de Médecine Interne, 40 Avenue De Verdun, 94000, Creteil
Institut Gustave Roussy
Service de Réanimation (Département DIOPP), 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Assistance Publique Hopitaux De Paris
Service des Maladies Infectieuses et Tropicales, 1 Avenue Claude Vellefaux, 75010, Paris
Assistance Publique Hopitaux De Paris
Service de Médecine Interne, 100 Boulevard Du General Leclerc, 92110, Clichy
Assistance Publique Hopitaux De Paris
Services des Maladies Infectieuses, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Addendum 1_Serious Adverse Events notification form_2024-514244-81-00 | 1-1 |
| Protocol (for publication) | D1_Addendum 2_Pregnancy notification form_2024-514244-81-00 | 1-1 |
| Protocol (for publication) | D1_Addendum 4_Description of the CT in the AP-HP Trials Register_2024-514244-81-00 | 1-1 |
| Protocol (for publication) | D1_Protocol_2024-514244-81-00_For publication | 1-2 |
| Protocol (for publication) | D4_Patient facing document_Patient Card_2024-514244-81-00 | 1-1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments | 1-1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_majeur | 1-1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_nifc-Majeur-Hors Etat exprimer consentement-pdc-famille | 1-1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_nifc-riph1-majeur_poursuite | 1-1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ANUDULAFUNGINE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ANUDULAFUNGINE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CASPOFUNGIN 50 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CASPOFUNGIN 50 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUCONAZOLE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC FLUCONAZOLE 100mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC MICAFUNGINE_100mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Voriconazole | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC voriconazole 200 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ambisome_liposomal_50mg_27032025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ambisome_liposomal_50mg_27032025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_MICAFUNGINE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-514244-81-00 | 1-2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-514244-81-00 | 1-2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-01 | France | Acceptable 2025-11-14
|
2025-11-19 |