E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
S. aureus bloodstream infections |
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E.1.1.1 | Medical condition in easily understood language |
Blood infections, including heart valve infections |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014665 |
E.1.2 | Term | Endocarditis |
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10077008 |
E.1.2 | Term | Methicillin-sensitive Staphylococcus aureus infection |
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 | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003997 |
E.1.2 | Term | Bacteraemia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041937 |
E.1.2 | Term | Staphylococcus aureus endocarditis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021839 |
E.1.2 | Term | Infection MRSA |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054637 |
E.1.2 | Term | Staphylococcal bacteremia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 describe the safety and tolerability of CF-301 vs. placebo in addition to SOC antibacterial therapy for the treatment of patients with S. aureus BSIs including endocarditis.
• To estimate clinical outcome at Day 14 after CF 301/placebo administration.
• To describe the PK parameters of CF-301. |
|
E.2.2 | Secondary objectives of the trial |
• To estimate clinical outcome at Day 7 after CF-301/placebo administration, at the end of SOC antibacterial therapy (EOT), and at test-of-cure (TOC) 28 days after the EOT.
• To estimate microbiological response at Days 7 and 14 after CF-301/placebo administration.
• To estimate microbiological outcome at EOT and at TOC |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• male or female, 18 years or older.
• blood culture positive for S. aureus.
• at least two signs or symptoms attributable to S. aureus bacteremia.
• known or suspected endocarditis by Modified Duke Criteria and/or known or suspected complicated S. aureus BSI.
• patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential. |
|
E.4 | Principal exclusion criteria |
• patient previously received CF-301.
• treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 72 hours within 7 days before randomization.
• presence of any removable infection source that will not be removed or debrided within 72 hours after randomization.
• presence of infected prosthetic joint or presence of a prosthetic cardiac valve, cardiac valve support ring, or other implantable cardiac device.
• known or suspected endocarditis, brain abscess or meningitis.
• pneumonia or known polymicrobial bacteremia.
• patient is employed by the sponsor or investigational site or is a first degree relative of a person employed by the sponsor or investigational site; patient is institutionalized by administrative or court order. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Safety and tolerability of CF-301 vs placebo in addition to standard-of-care antibacterial therapy
• Clinical outcome at Day 14 after CF-301/placebo administration
• pharmacokinetic parameters of CF-301
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Safety and tolerability of CF-301: Time of consent through test of cure
• Clinical outcome at Day 14 after CF-301/placebo administration
• PK parameters of CF-301: subsets of patients will give serial PK samples from either pre-dose through 48 hours, between 2.25 hours and 24 hours or 2.25 hours and 48 hours after the start of the study drug infusion |
|
E.5.2 | Secondary end point(s) |
• Clinical outcome at Day 7 after CF301/placebo administration
• Clinical outcome at the end of SOC antibacterial therapy (EOT), and at test of cure (TOC), and 28 days after EOT
• Microbiological response
• Microbiological outcome
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Clinical outcome: at Day 7 after CF-301/placebo administration, end of standard of care antibacterial therapy (EOT), at test of cure, 28 days after end of standard of care therapy
• Microbiological response: at Days 7 and 14 after CF-301/placebo administration
• Microbiological outcome at End of therapy and Test of cure (28 days after end of therapy)
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Argentina |
Belgium |
Bulgaria |
Chile |
Czech Republic |
France |
Germany |
Greece |
Guatemala |
Israel |
Italy |
Russian Federation |
Spain |
United Kingdom |
United States |
|
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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |