TABLE 6.
Results of clinical trials involving linezolid in adults
| Results | |||||||
|---|---|---|---|---|---|---|---|
| Reference (date) | Design | n ( ) | Indication | Regimen | Duration (days) | Clinical cure | Microbiological cure† |
| Pharmacia and Upjohn study 51 (August 1999) | Prospective, single-blind, comparative | 548 (417) | CAP (outpatient) | Linezolid 600 mg q 12 h versus cefpodoxime proxetil 200 mg q 12 h | 10-14 | Linezolid 199/205 (97.1%)† cefpodoxime 204/212 (96.2%)† | Linezolid 87.8% Cefpodoxime 89.4% |
| Pharmacia and Upjohn study 33 September 1999 Cammarata et al (68) | Prospective, randomized, open-label (initially evaluator blind), comparative | 747 (534) | CAP (with hospital admission) | Linezolid IV 600 mg q 12 h followed by oral 600 mg q 12 h versus ceftriaxone IV 1 g q 12 h followed by oralcefpodoxime 200 mg q 12 h; (aztreonam IV 1-2 g q 8 h could be used in linezolid group for Gram-negative coverage) | 7-14 | Linezolid 247/272 (90.8%)‡ Ceftriaxone/cefpodoxime 225/254 (88.6%) (8 patients' data missing or indeterminate) | Linezolid: 89.9% Ceftriaxone/cefpodoxime 87.1% |
| Pharmacia and Upjohn study 48a (September 1999) Rubinstein et al (74) | Prospective, randomized, double-blind | 396 (204) | Nosocomial pneumonia | Linezolid IV 600 mg q 12 h versus vancomycin IV 1 g q 12 h (aztreonam IV 1 to 2 g q 8 h used to Gram negative coverage) | 7-21 | Linezolid 71/107 (66.4%)‡ and vancomycin 62/91 (68.1%) | Linezolid 36/53 (67.9%) and vancomycin 28/39 (71.8%) |
| Pharmacia and Upjohn study 39 (August 1999) | Prospective, randomized, double-blind comparative | 332 (251) | Various, uncomplicated skin and soft tissue infection | Linezolid 400 mg bid versus clarithromycin 250 mg bid | 7-14 | Linezolid 118/127 (92.9%)† Clarithromycin 115/124 (92.7%)† | Linezolid 98.1% Clarithromycin 97.1% |
| Pharmacia and Upjohn, study 39a (August 1999) | Prospective, randomized, double-blind, comparative | 753 (623) | Various, tissue uncomplicated skin and soft infection | Linezolid 400 mg bid versus clarithromycin 250 mg bid | 7-14 | Linezolid 299/314 (95.2%)† clarithromycin 287/309 (92.9%)† | Linezolid 90.9% Clarithromycin 84.1% |
| Stevens et al (76) | Prospective, randomized, double-blind, double-dummy | 826 (600) | Various, complicated skin or deeper soft tissue infection, may have required surgical intervention | Linezolid IV or oral 600 mg q 12 h versus oxacillin IV 2 g q 6 h or oral dicloxacillin 500 mg q 6 h | 10-21 | Linezolid 264/298 (88.6%)† oxacillin/dicloxacillin 259/302 (85.8%)† | Linezolid 88.1% Oxacillin/cloxacillin 86.1% |
Clinical Cure Not defined (eg, in terms of total resolution of symptoms or improvement in chest radiograph, etc.);
*
Microbiological success rates (based on microbiologically evaluable population);
†
Investigator's Assessment of Clinical Outcomes;
‡
Included Investigator's Assessment of Clinical Outcome, Sponsor's Assessment of Clinical Outcomes and Patient Overall Outcome.