E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bloodstream infection (bacteremia) or hospital-acquired pneumonia by Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacin |
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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 | 10060562 |
E.1.2 | Term | Bacteremia, unspecified |
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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 | 10064977 |
E.1.2 | Term | Acinetobacter bacteremia |
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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 | 10054228 |
E.1.2 | Term | Gram-negative bacteremia |
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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 | 10054279 |
E.1.2 | Term | Escherichia coli bacteremia |
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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 | 10054281 |
E.1.2 | Term | Escherichia bacteremia |
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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 | 10058883 |
E.1.2 | Term | Klebsiella bacteremia |
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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 | 10058884 |
E.1.2 | Term | Enterobacter bacteremia |
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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 | 10058925 |
E.1.2 | Term | Serratia bacteremia |
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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 | 10058926 |
E.1.2 | Term | Hemophilus bacteremia |
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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 | 10058927 |
E.1.2 | Term | Pseudomonal bacteremia |
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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 | 10052596 |
E.1.2 | Term | Nosocomial pneumonia |
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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 characterize the disposition of colistin in plasma in critically-ill patients |
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E.2.2 | Secondary objectives of the trial |
1.To determine the clearance of colistin via renal replacement therapy 2. Toestablish the co-variates influencing the pharmacokinetics of colistin. 3. To establish the inter-relationships of the pharmacokinetics and pharmacodynamics of colistin with bacteriological and clinical outcomes 4. To investigate inter-relationships between the pharmacokinetics of colistin, duration of therapy and patient characteristics with development of bacterial resistance to colistin. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient of 18 years of age or older 2. Expectation of hospitalization of ≥ 48 hours 3. Receipt of intravenous colistin for clinical care 4. Provision of written informed consent by the patient or by a relative legally able to give proxy consent if the patient cannot give consent 5. Infection is defined by Center for Disease Control and Prevention (CDC) definitions of bloodstream infection (bacteremia) or hospital-acquired pneumonia:85 6. Patient must have growth from blood culture or a respiratory specimen culture of a Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropenem, piperacillin/tazobactam, ciprofloxacin OR levofloxacin 7. Adequate venous access to enable collection of blood for determination of CMS and generated colistin in plasma
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E.4 | Principal exclusion criteria |
1. Currently pregnant or breastfeeding 2. Currently incarcerated 3. Concomitant use of colistin or polymyxin B delivered directly into the respiratory tract 4. Known allergy to colistin or polymyxin B 5. Cystic fibrosis 6. Estimated life expectancy of less than one week
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E.5 End points |
E.5.1 | Primary end point(s) |
To characterize the disposition of colistin in plasma in critically-ill patients |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
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 |