Table 1.
Summary of main recent clinical trials with moxifloxacin in adult and old patients with community acquired-pneumonia
| Authors | Study design | No. of patients PPP | Treatment | Test of cure (TOC) | Clinical success in PPP (%) |
Bacteriological successa No. of patients (%) |
Age mean values ± SD(range) | PSI classb |
|---|---|---|---|---|---|---|---|---|
| Fogarty 1999 | Randomized double-blind | 382 | 10 days MXF po 400 mg od (n = 194) | End of therapy | 97.0 | 99 (97.0) | 48 | NA |
| 10 days CLA po 500 mg bid (n = 188) | 95.0 | 100 (93.0) | 49 | |||||
| Patel 2000 | Open-label non comparative | 196 | 10 days MXF po 400 mg od | 0–6 days post therapy | 94.0 | 106 (91.0) | 49 (18–85) | NA |
| Hoeffken 2001 | Randomized double-blind | 531 | 10 days MXF po 200 mg od (n = 180) | 3–5 days post therapy | 93.9 | 29 (72.5) | 48.4 ± 20.6 | NA |
| 10 days MXF po 400 mg od (n = 177) | 94.4 | 37 (78.7) | 48.0 ± 20.8 | |||||
| 10 days CLA po 500 mg bid (n = 174) | 94.3 | 29 (70.7) | 48.2 ± 19.2 | |||||
| Petitpretz 2001 | Randomized double-blind | 362 | 10 days MXF po 400 mg od (n = 177) | 3–5 days post therapy | 91.5 | 61 (89.7) | 52.0 ± 20.5 (≥70: 25%) | NA |
| 10 days AMX po 1000 mg tid (n = 185) | 89.7 | 56 (82.4) | 49.9 ± 20.6 (≥70: 22%) | |||||
| Finch 2002 | Randomized open-label | 538 | 7–14 days MXF iv/po 400 mg od (n = 258) | 5–7 days post therapy | 93.4 | 60 (93.7) | 55.2 ± 20.6 | NA |
| 7–14 days AMX-CLAV iv(1200 mg tid)/po (625 mg tid) ± CLA iv/po (500 mg bid) (n = 280) | 85.4 | 58 (81.7) | 55.9 ± 19.6 | |||||
| Torres 2003 | Randomized double-blind | 446 | Up to 14 days MXF po 400 mg od (n = 215) | 7–10 days post therapy | 93.5 | NA | 52.7 ± 18.7 (≥70: 22%) | I–III 80.6% |
| IV 17.6% | ||||||||
| V 1.7% | ||||||||
| Up to 14 days AMX (1000 mg tid) or CLA (500 mg bid) alone or in combination (n = 231) | 93.9 | NA | 49.3 ± 18.7 (≥70: 18%) | I–III 84.9% | ||||
| IV 13.9% | ||||||||
| V 1.2% | ||||||||
| Jardim 2003 | Randomized double- blind CAP with S. pneumoniae infection | 70 | 10 days MXF po 400 mg od (n = 34) | 3–5 days post therapy | 94.1 | 15 (88.2) | 51.9 (>65: 28.2%) | NA |
| 10 days AMX 500 mg tid (n = 36) | 91.7 | 14 (87.5) | 48.6 (>65: 31.1%) | |||||
| Katz 2004 | Randomized open- label | 221 | 7–10 days MXF iv/po 400 mg od (n = 108) | 7–14 days post therapy | 83.3 | 14 (82.3) | 59.4 ± 19 (18–93) | I–III 75.0% |
| IV 20.0% | ||||||||
| V 5.0% | ||||||||
| 7–10 days CRO (2000 mg iv qd) → FUR (500 mg po bid) ± AZM ± MTZ (n = 113) | 79.6 | 15 (62.5) | 58.7 ± 20.5 (18–94) | I–III 77.0% | ||||
| IV 18.0% | ||||||||
| V 5.0% | ||||||||
| Portier 2005 | Randomized open-label | 289 | 10 days MXF po 400 mg od (n = 151) | 5–7 days post therapy | 86.8 | 23 (76.7) | 59.3±17.9 (>65: 46.8%) | NA |
| 10 days AMX-CLAV (1000/125 mg tid) + ROX (150 mg bid) (n = 138) | 87.0 | 23 (74.2) (>65: 53.1%) | 62.4±18 | |||||
| Fogarty 2005 | Pooled data from 6 non-comparative trials (S.pneumoniae CAP) | 131 | 7–14 days MXF po or iv/po 400 mg od | 7–35 days post therapy | 95.4 | 104 (92.9) | 56.4 (20–88) | NA |
| Welte 2005 | Randomized open-label | 317 | 7–14 days MXF iv/po 400 mg od (n = 161) | 5–20 days post therapy | 85.7 | NA | (≥65: 43.5%) | I–III 83.2% |
| IV 16.1% | ||||||||
| V 0.6% | ||||||||
| 7–14 days CRO (2000 mg od) ± ERY(1000 mg iv tid) (n = 156) | 86.5 | NA | (≥65: 41.0%) | I–III 82.7% | ||||
| IV 16.7% | ||||||||
| V 0.6% | ||||||||
| Anzueto 2006 | Randomized double-blind | 281 | 7–14 days MXF iv/po 400 mg od (n = 141) | 5–21 days post therapy | 92.9 | 17 (81.0) | 77.9±7.1 (65–95) (>75: 64.5% | I–III 48.2% |
| IV 29.1% | ||||||||
| V 7.1% | ||||||||
| 13.5% c | ||||||||
| 7–14 days LEV iv/po 500 mg od (n = 140) | 87.9 | 21 (75.0) | 77.4±7.7 (65–98) | I–III 40.7% | ||||
| IV 36.4% | ||||||||
| V 4.3% | ||||||||
| 18.6% c |
a
eradication/presumed eradication in microbiologically valid population.
b
PSI, pneumonia severity index score (Fine et al 1997).
c
severe ATS CAP severity score according to guidelines of the American Thoracic Society (Niederman et al 2001).
Abbreviations: AMX, amoxicillin; AMX-CLA, amoxicillin-clavulanate; AZM, azithromycin; CLA, clarithromycin; CRO, ceftriaxone; ERY, erithromycin; FUR, cefuroxime; LEV, levofloxacin; MTZ, metronidazole; MXF, moxifloxacin; n, number of patients; PPP, per-protocol population; ROX, roxithromycin.