E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Critical illness, ventilator associated pneumonia |
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E.1.1.1 | Medical condition in easily understood language |
Seriously unwell patients in intensive care with lung infections |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065153 |
E.1.2 | Term | Ventilator associated pneumonia |
E.1.2 | System Organ Class | 100000004862 |
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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 |
The primary object of this study is to investigate changes over time in blood and lung concentrations of piperacillin and tazobactam in critically ill patients. |
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E.2.2 | Secondary objectives of the trial |
1. To investigate how much and how quickly piperacillin irreversibly binds to protein in the blood. 2. To investigate how the permaebilty of the lung to fluid affects the concentration of antibiotic in the lung. 3. To investigate if different types of infectious organisms affect the variability in drug levels seen in critically ill patients. 4. To investigate if the amount of inflammation affects the variability in drug levels seen in critically ill patients. 5. To collect the bacteria and fungus from this very specific group of patients for future laboratory studies. 6. To see how antibiotics affect the bacteria and fungus growing on the endotracheal tube of critically ill patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject is an adult aged 18 to 85 2. Subject requires or has been commenced on piperacillin/tazobactam as directed by clinical Intensive Care Unit medical staff
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E.4 | Principal exclusion criteria |
1. Subject is known to be intolerant of β-lactams antibiotics 2. Subject has an infection with a piperacillin/tazobactam resistant organism (i.e. P. aeruginosa with MIC ≥16 mg/L, other organism with MIC ≥ 8mg/L) or organisms with inherent resistance (e.g. Stenotrophomonas) 3. Subject is immunocompromised (neutropenia, HIV/AIDS) 4. Subject is unlikely to survive longer the 48 hours 5. Subject is pregnant or breast-feeding or plans to become pregnant during the course of the study 6. Subject is enrolled in another Clinical Trial of an Investigational Medical Product. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is blood and lung concentrations of piperacillin and tazobactam. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Five days of piperacillin/Tazobactam |
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E.5.2 | Secondary end point(s) |
1. All cause mortality 28 days after commencing antibiotics 2. Microbiological clearance of infection 3. Number of ventilator-free days |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Mortality and ventilator free days will have an endpoint of 28 days. Microbiological clearance of infection has an endpoint of 5 days. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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 trial will end when 40 patients have been recruited and followed up until discharge from hospital or 30 days after the end of piperacillin/tazobactam administration – whichever is sooner. |
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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 |