E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MRSA-positive, morbidly obese patients with pneumonia |
Morbide obese, MRSA positieve, patiënten die lijden aan een pneumonie |
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E.1.1.1 | Medical condition in easily understood language |
MRSA-positive, morbidly obese patients with pneumonia |
Morbide obese, MRSA positieve, patiënten die lijden aan een pneumonie |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053024 |
E.1.2 | Term | Pneumonia gram-positive bacterial |
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 |
Evaluation of the linezolid unbound and total plasma levels and their variability in MRSA-positive, morbidly obese patients with pneumonia, after repeated intravenous administration of linezolid.
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E.2.2 | Secondary objectives of the trial |
Determination of the probability of PK/PD target attainment (PTA) by MIC against MRSA.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patient age 18 years or more
• BMI >35 (BMI = weight (kg) / height2 (m2))
• Radiographically and clinically documented pneumonia and one of the following:
- the patient is MRSA screen-positive and is as such at high risk for MRSA pneumonia (MIC for linezolid is known or possible to assess)
- the patient has a baseline respiratory tract sample positive for MRSA; MRSA pneumonia is likely
- empiric therapy without linezolid is initiated (no obvious indication for MRSA involvement), but the patient is switched to linezolid therapy once culture results demonstrate MRSA as pathogen. CAVE: the patients must be included in the study prior to the moment the first trough sample must be drawn. As such, patients becoming MRSA-positive after >1 dose of linezolid cannot be included in the study.
• Decision to start treatment with linezolid for at least 3 days (6 doses of 600 mg).
• Patient is colonized or infected with MRSA (at any site) and it must be possible to send a fresh isolate to the central laboratory for microbiology
• Written informed consent by the patient or his/her legal representative.
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E.4 | Principal exclusion criteria |
Exclusion from participation in the study is left at the discretion of the treating physician.
Contraindications as described in the SmPC may serve as a basis for patient exclusion. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics and pharmacodynamics of linezolid
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood samples collection during 84 hours after administration of the first dose of linezolid
12 hour urine collection after administration of the 6th or 7th dose of linezolid
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E.5.2 | Secondary end point(s) |
Determination of linezolid MICs |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | Yes |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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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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 |