E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pneumonia complicated urinary infection complicated abdominal infection complicated skin and soft tissue infection acute bacterial meningitis |
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E.1.1.1 | Medical condition in easily understood language |
pneumonia complicated infection of the kidneys or the urinary bladder complicated infection of the abdominal cavity complicated infection of the skin or soft tissues acute bacterial meningitis |
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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 | LLT |
E.1.2 | Classification code | 10049582 |
E.1.2 | Term | Soft tissue infection NOS |
E.1.2 | System Organ Class | 100000004862 |
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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 | 10040874 |
E.1.2 | Term | Skin infection NOS |
E.1.2 | System Organ Class | 100000004862 |
|
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 | 10046576 |
E.1.2 | Term | Urinary tract infection, site not specified |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035725 |
E.1.2 | Term | Pneumonia NOS |
E.1.2 | System Organ Class | 100000004862 |
|
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 | 10056570 |
E.1.2 | Term | Intra-abdominal infection |
E.1.2 | System Organ Class | 100000004862 |
|
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 |
Determination of penetration of IMPs into the epithelial lining fluid in intensive care unit patients |
|
E.2.2 | Secondary objectives of the trial |
Exploratory analysis of patient specific characteristics as covariates of IMP penetration into epithelial lining fluid |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age 18 years or more - mechanical ventilation via a endotracheal tube or cannula - continuous infusion of an IMP prescribed by the attending physician due to suspected or proven infection - informed consent by the patient or the legal representative |
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E.4 | Principal exclusion criteria |
- simultaneous participation in another clinical trial - renal replacement therapy - contraindications against bronchoscopy (e.g. coagulopathy, extremely compromised pulmonary gas exchange) - hypersensitivity to meropenem or to other carbapenems - severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to other betalactam antibiotics (e.g. penicillins, cephalosporins) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Concentration of the IMPs in plasma and epithelial lining fluid, determination of the penetration. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
correlation of the penetration of the IMPs into epithelial lining fluid with routine patient characteristics (e.g. age, weight, height, renal function markers, underlying disease) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 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.8.5 | 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
|
Date of acceptance for publication in a peer reviewed journal. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |