E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Invasive fungal infection (IFI) in lung transplant patients with and without cystic fibrosis. |
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E.1.1.1 | Medical condition in easily understood language |
Invasive Fungal 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 | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049085 |
E.1.2 | Term | Antifungal prophylaxis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
a) To estimate the time taken to achieve a steady level (steady state) of posaconazole in the blood in cystic fibrosis (CF) and non-CF transplant recipients. b) To examine the relationship between blood posaconazole levels and posaconazole levels in the lungs in cystic fibrosis (CF) and non-CF transplant recipients. |
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E.2.2 | Secondary objectives of the trial |
To assess fungal infection rates in the CF and non CF populations at weeks 6 and 12 post transplant. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Each patient must be willing and able to provide, and give, written informed consent for the trial. 2.Each patient must be scheduled to undergo lung transplantation. 3.Each patient must be ≥ 18 years of age and may be of either sex or any race/ethnicity. 4.Each patient must be able to adhere to dose and visit schedules. 5.Each patient must be able to take oral/nasogastric medication. 6. Patients undertake not to become pregnant during the study. Women of childbearing potential, male study participants and the sexual partners of men participating in this study must use an effective method of birth control while taking part in this study and for a period of six weeks after completion of the study. |
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E.4 | Principal exclusion criteria |
1.Hypersensitivity/previous reaction to posaconazole and related compounds, 2.Severe liver disease (Child –Pugh classification C), 3.Current use of ergot alkaloids or hydroxymethyl-coenzyme A (HMG-CoA) reductase inhibitors (simvastatin, lovastatin and atorvastatin) within 7 days prior to transplant. Pravastatin is permitted, 4.Current use of CYP3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days prior to transplant, 5.Treatment with posaconazole within 14 days prior to transplant, 6.The patient or a family member is among the investigational or sponsor staff directly involved with this trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Coprimary Pharmacokinetic Endpoint is related to the Primary Trial Objective. The Coprimary Pharmacokinetic Endpoints for the trial are: 1. Time to reach steady state plasma posaconazole level. 2. Posaconazole AC level and concurrent plasma posaconazole level. |
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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) |
The secondary endpoint is the incidence of fungal infections in CF and non-CF patients. Fungal Infection will be assessed according to the EORTC/MSG consensus criteria. Patients will be monitored continuously for signs of infection according to the standard care protocol at the site. During the study, only if a fungal infection is suspected will this data be recorded in the CRF. This data will be collected retrospectively at the Day 42 and 84 or discontinuation assessments. |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | 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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | No |
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 overall trial ends when the last remaining patient has ended participation in the trial, by completing the trial, being discontinued from the trial, or being lost to follow-up. |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |