E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients ayant des brûlures étendues et graves. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006794 |
E.1.2 | Term | Burns classified according to extent of body surface involve |
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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 |
Etudier les paramètres pharmacocinétiques de la caspofungine chez les patients sévèrement brûlés, afin de déterminer la posologie optimale. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- adultes entre 18 et 60 ans, - ayant une surface brûlée comprise entre 20 et 60% de la surface corporelle totale, - brûlure datant d'au moins 8 jours et ne dépassant 15 jours - n'ayant pas eu de geste chirurgical - non atteints d'une infection fongique, - devant être hospitalisés au moins 5 jours - ayant signé un consentement éclairé - bilan biologique datant de moins de 24h
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E.4 | Principal exclusion criteria |
- Espérance de vie inférieure à 5 jours, - chirurgie prévue dans les 5 jours - femme enceinte, - contre-indication connue à la caspofungine : hypersensibilité à la substance active ou à l'un des excipients (saccharose, mannitol, acide acétique glaciale et hydroxyde de sodium) - inclusion dans un autre protocole, - non affilié à un régime de sécurité sociale (bénéficiaire ou ayant droit). - Patient recevant un des traitements suivants : rifampicine, efavirenz, névirapine, phenobarbital, phénytoïne, carbamazépine - Patient ayant des transaminases 5 N
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E.5 End points |
E.5.1 | Primary end point(s) |
Les critères d'évaluation principaux sont les valeurs moyennes de l'aire sous la courbe des concentrations plasmatiques de caspofungine de 0 à 24h, de la concentration au pic et de la concentration résiduelle à 24 h. Les critères secondaires sont les valeurs moyennes des paramètres pharmacocinétiques (clairances, volumes) de la caspofungine.
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | 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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |