E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Invasive candida infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007162 |
E.1.2 | Term | Candidiasis of the intestine |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007152 |
E.1.2 | Term | Candidiasis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
assess the incidence of invasive candidiasis at EOT assess the time to invasive candidiasis at EOT |
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E.2.2 | Secondary objectives of the trial |
Assess incidence and time to confirmation of the composite endpoint (defined as IFI and/or administration of alternative anti-fungal therapy). Assess the emergence or persistence of fungal colonization Assess the level of organ dysfunction: Change in SOFA score over time, Need for re-intubation, Need for renal support, Need for vasopressor support, Assess the requirement for additional abdominal surgery/intervention. To investigate: All-cause mortality at 28 days and 90 days after end of treatment; Organ failure-free days from Day 1 until 28 days after end of treatment; Fungal-free survival up to 28 days after end of treatment; ICU-free days from Day 1 until 28 days after end of treatment Incidence of nosocomial pneumonia Assess resource use and health-related quality of life at the End of Study (EOS) visit. 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.Localised or generalised 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. 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. |
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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. Severe liver insufficiency, advanced liver fibrosis, cirrhosis or hepatitis 13. 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. 14. Any concomitant medical condition that could interfere with the study conduct and protocol procedures or contraindicate subject’s participation in the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of invasive fungal infection Time to invasive fungal infection |
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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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of treatment and End of Study |
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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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
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 | No |
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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The long term follow up visit of the last subject undergoing the trial is considered the end of the trial - see protocol. |
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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 |