| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Catheter related gram positive bloodstream infection |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10007810 |
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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 objective of this study is to compare the microbiological efficacy of linezolid to vancomycin/oxacillin/dicloxacillin in the empiric treatment of patients with gram-positive catheter-related bloodstream infections. |
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
| To be eligible for this study, a patient must provide informed consent and must meet all of the following criteria. No study procedures including any baseline tests should be performed until the patient (or parent/legally acceptable representative, if appropriate) legally signs the informed consent form.1. Male or female 13 years of age or older (unless restricted to 18 years of age based on local regulatory requirements) and ³ 40 kg body weight.2. Signs and symptoms of a localized catheter-related infection (tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site) OR body temperature of ³ 38.0 °C or <36 °C orally WITH one of the following: • Hypotension, defined as systolic blood pressure < 90 mmHg or its reduction by ³40 mmHg from the patient’s baseline, in the absence of other causes for hypotension. • Tachycardia defined as a pulse rate > 90 beats per minute. • Tachypnea defined as a respiratory rate > 20 breaths per minute or PACO2 <32 torr. • White blood count > 12,000 cells/mm3 or < 4,000 cells/mm3, or with a differential count showing > 10% band neutrophil forms.3. Patients with short-term, nontunneled, central venous catheters, pulmonary artery catheters and arterial catheters in place for at least 3 days. Long-term tunneled central venous catheters and temporary hemodialysis catheters (e.g. Quinton) will be permitted if the investigator is willing to pull the infected catheter at baseline for catheter tip culture. Patients may have more than one concurrent catheter. Multilumen and antibiotic coated or impregnated catheters are permitted if the signs/symptoms of catheter infection are present.4. Two blood samples must be obtained and cultured: one from the infected catheter and the other from a peripheral percutaneous site. The catheter must then be removed and the tip cultured.5. Willing to return for the EOT and follow-up (F-U) visits. |
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| E.4 | Principal exclusion criteria |
| The presence of any of the following will exclude a patient from study enrollment:1. Catheter-related bloodstream infections caused by gram-negative bacteria only, fungi only or a mixed population of bacterial and fungal pathogens.2. Patients with long-term, tunneled catheters such as Hickman, Broviac, or Groshung catheters that the investigator is not willing to pull at baseline for tip culture.3. Patients with evidence of endovascular infections, such as clinical and/or echocardiographic evidence of endocarditis, prosthetic cardiac valves, vascular grafts, septic thrombophlebitis.4. Patients without a pre-existing vascular access device with community-acquired bacteremia.5. Patients with evidence of other infections resulting in bacteremia, such as clinical or radiographic signs of osteomyelitis, skin/skin structure infection, pneumonia, urinary tract infection, joint infection, intra- abdominal infection, or other infection known to be due to the organism cultured from the blood.6. Patients in whom the vascular catheter cannot be removed.7. The insertion of a new catheter into the former insertion site as the pulled catheter (i.e., changing a catheter over a guidewire).8. Patients with infections related to permanent intravascular devices such as vascular grafts and hemodialysis catheters, implantable pacemakers or defibrillators; intra-aortic balloon pumps, and left ventricular assist device; intravascular transplants such as prosthetic cardiac valves; or nonintravascular devices such as peritoneal dialysis catheters; or neurosurgical devices such as ventriculo-peritoneal shunts, intra-cranial pressure monitors, or epidural catheters.9. High probability, in the investigator’s opinion, that catheter removal alone will cure the infection.10. Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant.11. Identification of a pathogen resistant to linezolid or vancomycin.12. Patients who are unlikely to survive through the treatment period and evaluation.13. Administration of previous antibiotic treatment (for infection) for more than 24 hours within 72 hours of study entry unless the pathogen showed drug resistance or the treatment failed (with failure defined as no clinical improvement after 3 days of treatment).14. Known pheochromocytoma, carcinoid syndrome, uncontrolled hypertension, or untreated hyperthyroidism.15. Previous enrollment in this protocol or another linezolid protocol.16. Hypersensitivity to linezolid or vancomycin or one of their excipients (or aztreonam or aminoglycosides if gram negative coverage is required).17. Concurrent use of another investigational medication or use within 30 days of study entry.18. CD4 Cell Count <200 cells/mm3 secondary to HIV infection.19. Inability to tolerate 300 mL of fluid every 12 hours. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary endpoint used to assess this objective will be patient microbiological outcome at the short-term follow-up (STFU) visit which is also the test of cure (TOC) visit. |
|
| 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 | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| 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 | 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 | 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
|
| 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.8.5 | The trial involves multiple Member States | Yes |
| 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 | Information not present in EudraCT |
| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 2 |
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