E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007152 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007162 |
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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 |
To assess the incidence of confirmed invasive fungal infection (IFI) in both study arms at the end of treatment (EOT) visit.
To assess the time to confirmed IFI in both study arms. |
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E.2.2 | Secondary objectives of the trial |
To assess the incidence and the time to confirmation of the composite endpoint in both study arms at EOT visit. To assess the emergence or persistence of fungal colonization in both study arms at EOT. To assess the level of organ dysfunction: Change in sequential organ failure assessment (SOFA) score over time, Need for re-intubation, Need for renal support, Need for vasopressor support, To assess the requirement for additional abdominal surgery/intervention. To investigate: All-cause mortality at 28 days and 90 days after end of study drug treatment; Organ failure-free days from Day 1 until 28 days after end of study drug treatment; Fungal-free survival up to 28 days after end of study drug treatment; Intensive Care Unit (ICU)-free days from Day 1 until 28 days after end of study drug treatment To perform a health economic assessment of resource use. To assess health-related quality of life (QoL). To assess the safety of micafungin when used as pre-emptive treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. ≥ 18 years of age. 2. Intra-abdominal infection requiring surgery and ICU stay. 3. If CAI, duration of ICU stay of ≥ 72 hrs (but not more than 120 hours), counted from the end of surgery, and a further expected duration of ICU stay of ≥ 48 hours or more. 4. If NAI, duration of ICU stay of ≤ 48 hrs, counted from the end of surgery, and a further expected duration of ICU stay of ≥ 48 hours or more. 5. Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study. A highly effective method of birth control is defined as those which result in a low failure rate ( i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. 6. The subject has been fully informed and has given written informed consent to participate in the study. Witnessed informed consent is accepted in case the subject is capable of making the decision but not capable of signing the document. Subjects who lack the capacity to give consent may be included in the study with a relative/legal representative written agreement for the subject to participate according to the local law of the country. If during the course of the study drug treatment the subject condition changes and is capable of providing consent, then this will be obtained. |
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E.4 | Principal exclusion criteria |
1. Acute pancreatitis. 2. Neutropenia (ANC < 1,000/mm3) at the time of randomization. 3. Infected intra-peritoneal dialysis. 4. Patients undergoing solid organ transplantation. 5. Documented invasive candidiasis at the time of randomization. 6. Expected survival < 48 hours. 7. Any systemically active anti-fungal administered within 14 days prior to administration of the study drug. 8. Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients. 9. Currently receiving and/or has taken an investigational drug within 28 days prior to randomization.. 10. Pregnant woman or breast-feeding mother. 11. �Do Not Resuscitate� order. 12. The subject, in the opinion of the investigator, may find it difficult to adhere to the provisions of treatment and observation specified in the protocol. 13. The subject has any clinical condition, diagnosis, symptomatology or ongoing investigation, which, in the opinion of the Investigator, contraindicates their participation in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of confirmed IFI Time to confirmed IFI |
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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 | Yes |
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 | Yes |
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 | 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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 53 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |