E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Candida bloodstream infections/ candidemia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042938 |
E.1.2 | Term | Systemic candida |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042939 |
E.1.2 | Term | Systemic candidiasis |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049160 |
E.1.2 | Term | Candidaemia |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053166 |
E.1.2 | Term | Candida sepsis |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060573 |
E.1.2 | Term | Candidemia |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013431 |
E.1.2 | Term | Disseminated candidiasis |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052240 |
E.1.2 | Term | Septicaemia candida |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054610 |
E.1.2 | Term | Septicemia candida |
|
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 evaluate the (preliminary) efficacy of interferon gamma as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia by assessment of a series of exploratory parameters. The primary endpoint is to compare the time to negative blood cultures. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are the overall survival, time to death, outcome of fungal infection (resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters) duration of antifungal therapy, duration of hospitalization and immunological parameters. A secondary aim will be to evaluate host response markers that could be used to identify patients with immunoparalysis who will benefit from immunotherapy, and to monitor the patient’s immunological response to IFN-gamma. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline). •Subjects who are 18 years old of age or older •Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 96 hours prior to study entry. •Subjects who have clinical evidence of infection AT SOME TIME WITHIN 96 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following: -Temperature >37.8 ˚C on 2 occasions at least 4 hours apart or one determination measurement > 38.2 ˚C -Systolic blood pressure < 90 or a > 30 mmHg decrease in systolic BP from the subject’s normal baseline. -Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (eg, joint, skin, eye, bone, esophagus) -Radiologic findings of invasive canidiasis •Subject or their legal representative must sign a written informed consent form.
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E.4 | Principal exclusion criteria |
•Subjects with a history of allergy or intolerance to echinocandines or IFNgamma •Subjects with an absolute neutrophil count of less than 500/mm3 at study entry •Women who are pregnant or lactating •Subjects who are unlikely to survive more than 24 hours •Subjects who have failed previous systemic antifungal therapy for the Candida spp. infection which is being studied. •Subjects who have received more than 48 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the time to negative blood cultures. |
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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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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
|
The trial will end at week 8 after end of treatment of the last enrolled subject |
|
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 |