Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
448
Countries
1
Sites
22
yeast intra-abdominal infection, peritonitis
Decrease of failure rate at 28-day after the beginning of treatment in ITT analysis
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 6 Jan 2020 → ongoing
- Decision date (initial)
- 2024-08-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- DGOS
External identifiers
- EU CT number
- 2024-516266-11-00
- EudraCT number
- 2018-000407-16
- ClinicalTrials.gov
- NCT03580733
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Decrease of failure rate at 28-day after the beginning of treatment in ITT analysis
Secondary objectives 4
- Decreased crude 28 and 90-day mortality on ITT and PP analysis
- Increased success rate at the end of treatment on ITT and PP analysis
- Decreased serum ß-D-glucan concentration at the end of treatment
- Subgroup analysis for 28-day mortality: community-acquired versus healthcare-associated infections, timing of antifungal therapy (empiric or documented), C. albicans versus C. non-albicans, septic shock versus no shock
Conditions and MedDRA coding
yeast intra-abdominal infection, peritonitis
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Prospective multicenter randomized double-blind study Prospective multicenter randomized double-blind study comparing caspofungin to placebo for the treatment of ICU yeast intra-abdominal infection
|
Randomised Controlled | Double | [{"id":151517,"code":2,"name":"Investigator"},{"id":151518,"code":1,"name":"Subject"}] | Caspofungin: Patient treated 8 days by intravenous Caspofungin (double blind) Placebo: Patient received 8 days intravenous NaCl (double blind) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥ 18 years old
- Covered by national health insurance
- 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
- With written and signed informed consent
Exclusion criteria 6
- Allergy to caspofungin
- Life expectancy ≤ 48h
- Expected withdrawal of treatment
- Radiological drainage without surgery
- Severe hepatic impairment (Child-Pugh C score)
- Pregnant or lactating women
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 28-day failure rate after the beginning of treatment
Secondary endpoints 4
- 28 and 90-day mortality
- Success rate at the end of treatment
- Slope of ß-D-glucan concentrations
- 28-day mortality for subgroup analysis
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
CANCIDAS 70 mg powder for concentrate for solution for infusion
PRD2815103 · Product
- Active substance
- Caspofungin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 70 mg milligram(s)
- Max total dose
- 560 mg milligram(s)
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AX04 — CASPOFUNGIN
- Marketing authorisation
- EU/1/01/196/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CANCIDAS 50 mg powder for concentrate for solution for infusion
PRD2815102 · Product
- Active substance
- Caspofungin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 420 mg milligram(s)
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- J02AX04 — CASPOFUNGIN
- Marketing authorisation
- EU/1/01/196/001
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Sodium Chloride B Braun 0,9% süstelahus
PRD567891 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0.9 % percent
- Max total dose
- 0.9 % percent
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 271899
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Estonia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- DUPONT Hervé
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- DUPONT Hervé
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 448 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
ICU, 12 Rue Dubernat, Cs 91286, Talence
Hospices Civils De Lyon
ICU, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Assistance Publique Hopitaux De Paris
ICU, Porte 23, 1 Avenue Claude Vellefaux, Paris Cedex 10
Assistance Publique Hopitaux De Paris
ICU, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Rennes
ICU, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nantes
ICU, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Centre Hospitalier Universitaire De Saint Etienne
ICU, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire Amiens Picardie
ICU, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier De Versailles
ICU, 177 Rue De Versailles, Le Chesnay, Le Chesnay Rocquencourt
CHU Besancon
ICU, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Centre Hospitalier Universitaire De Dijon
ICU, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Assistance Publique Hopitaux De Paris
ICU, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Paris
ICU, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Les Hopitaux Universitaires De Strasbourg
ICU, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
CH Argenteuil
ICU, 69, rue du Lieutenant-Colonel Prudhon,, Argenteuil
CHRU De Nancy
ICU, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Centre Hospitalier Universitaire Rouen
ICU, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Nimes
ICU, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
Centre Hospitalier Universitaire De Lille
ICU, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centre Hospitalier Universitaire De Poitiers
ICU, 2 Rue De La Miletrie, 86000, Poitiers
Assistance Publique Hopitaux De Paris
ICU, 100 Boulevard Du General Leclerc, 92110, Clichy
Assistance Publique Hopitaux De Paris
ICU, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2020-01-06 | 2020-01-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocole 2024-516266-11-00 | 1 |
| Protocol (for publication) | D1_Protocole 2024-516266-11-00 clean | 1 |
| Protocol (for publication) | D1_PROTOCOLE_2024-516266-11-00 | 1.5 |
| Protocol (for publication) | D2_Synopsis 2024-516266-11-00 | 1 |
| Protocol (for publication) | D2_Synopsis 2024-516266-11-00 - Clean | 1 |
| Protocol (for publication) | D3_CSI conclusion CASPER | 1 |
| Protocol (for publication) | D3_CSI report CASPER | 1 |
| Recruitment arrangements (for publication) | NA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient - clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient pursuit | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patient pursuit - Clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_EMERGENCY | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_PATIENT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_PATIENT_SUBSEQUENT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_REPRESENTATIVE | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_REPRESENTATIVE_SUBSEQUENT | 1 |
| Subject information and informed consent form (for publication) | L1_Trusted person or close relative | 1 |
| Subject information and informed consent form (for publication) | L1_Trusted person or close relative - Clean | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC _Caspofungine_Dr Reddys | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC_Caspofungine_Cancidas_Merck | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC_Caspofungine_EG | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC_Caspofungine_OHRE PHARMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC_Caspofungine_TEVA | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOLE_SYNOPSIS_Fr_2024-516266-11-00 | 1.5 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-29 | France | Acceptable 2024-08-07
|
2024-08-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-14 | France | Acceptable 2025-11-27
|
2025-12-02 |