E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
intraabdominal yeast infection |
peritonite à levures |
|
E.1.1.1 | Medical condition in easily understood language |
intraabdominal yeast infection |
peritonite à levures |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
decrease of failure rate at 28-day after the beginning of treatment in ITT analysis |
diminution du taux d’échec 28 jours après le début du traitement en analyse en ITT |
|
E.2.2 | Secondary objectives of the trial |
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 |
-diminution de la mortalité brute à 28 et 90 jours pour les analyses en ITT et PP,
-augmentation du taux de succès en fin du traitement pour l'analyse ITT et PP,
- diminution de la concentration sérique de ß-D-glucane en fin de traitement,
-analyse de sous-groupe pour la mortalité à 28 jours : infections communautaires versus infections associées aux soins, type de traitement antifongique institué (empirique ou documentsdocumenté), C. albicans versus C. non-albicans, choc septique versus absence de choc
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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(1)
-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 |
- Âge ≥ 18 ans
- Couvert par l'assurance maladie
- Admis en réanimation après une intervention chirurgicale pour une péritonite avec suspicion de candidose intra-abdominale définie par :
o Soit un score de péritonite à levures ≥ 3 (1)
o Soit avec une candidose intra-abdominale documentée définie par un examen direct positif ou une culture positive de liquide péritonéal recueilli en peropératoire
- Signature d’un consentement (patient/représentant)
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|
E.4 | Principal exclusion criteria |
• 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
|
- Allergie à la caspofungine
- Espérance de vie ≤ 48h
- Arrêt des soins prévisible
- Drainage radiologique sans chirurgie
- Insuffisance hépatique sévère (score C de Child-Pugh)
- Femmes enceintes ou allaitantes
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E.5 End points |
E.5.1 | Primary end point(s) |
28-day failure rate after the beginning of treatment
|
Taux d’échec 28 jours après le début du traitement. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
28 and 90-day success rate at the end of treatment, slope of ß-D-glucan concentrations, 28-day mortality for subgroup analysis |
mortalité à 28 et 90 jours, taux de réussite à la fin du traitement, pente des concentrations de ß-D-glucane, mortalité à 28 jours pour les analyses de sous-groupe
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 32 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 39 |
E.8.9.1 | In the Member State concerned days | |