E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
complicated Urinary Tract Infection (cUTI) |
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E.1.1.1 | Medical condition in easily understood language |
complicated Urinary Tract Infection (cUTI) |
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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 | 10054088 |
E.1.2 | Term | Urinary tract infection bacterial |
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 | LLT |
E.1.2 | Classification code | 10079982 |
E.1.2 | Term | Complicated lower urinary tract infection |
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 |
• To evaluate the plasma and urine pharmacokinetics of LYS228 in patients with cUTI.
• To evaluate the clinical response to LYS228 compared to standard of care antibiotics for treating patients with cUTI
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E.2.2 | Secondary objectives of the trial |
• To evaluate the safety and tolerability of LYS228 in patients with cUTI
• To evaluate the microbiological response to LYS228 compared to standard of care antibiotics for treating patients with cUTI
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male and female patients 18 to 85 years of age with suspected and/or bacteriologically documented complicated UTI judges by the investigator to be serious (required patient to be hospitalized for treatment with intravenous antibiotics) |
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E.4 | Principal exclusion criteria |
-Urine Gram stain that demonstrated that a Gram-positive organism was present, or if urine culture results were available, demonstrated Grampositive organisms were present at ≥105 CFU/mL
-Urine culture result available at enrollment and demonstrating more than 2 different species of microorganisms regardless of the colony count
-Urine culture result available at enrollment and demonstrating fungal UTI with colony count >103 CFU/mL
-Patient had received prior antibiotics within 72 hours before the initiation of study therapy
-Patients with estimated glomerular filtration rate <30mL/min calculated based in study qualified formula |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Plasma PK parameters (AUCtau, Cmax, Tmax, CL, Vss, T1/2, %fT>MIC)
• Urine Ae0-6h and CLr
• Clinical success after completion of therapy (End of Study) determined by signs, and symptoms. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 5 for PK endpoints
Baseline, Day 7 for clinical endpoint |
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E.5.2 | Secondary end point(s) |
• Adverse events;Clinical laboratory tests; Vital signs
• Microbiological success after completion of therapy (End of Study) determined by quantitative urinary culture |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Daily for safety and tolerability endpoints
- Baseline, Day 7 for microbiological success |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard of care antibiotic |
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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 | 13 |
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 |
Czech Republic |
Denmark |
Germany |
Greece |
United States |
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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 last subject completed an end of study visit, and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator, or in the event of an early study termination decision, the date of that decision. |
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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |