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. 2006 Dec;2(4):417–434. doi: 10.2147/tcrm.2006.2.4.417

Table 4.

Clinical efficacy and tolerability of moxifloxacin in skin and skin structure infections (SSSIs)

Reference Study Design # evaluable subjects (C/B)a Regimens Results
Uncomplicated SSSIs
(1) MC/R/DB/PG 180/68 Moxi 400 mg PO qd × 7 days Clinical cure/improvement rates at 7–21d after the end of therapy were 90% (Moxi) and 91%
171/57 Ceph 500 mg PO tid × 7 days (Ceph) (p=NS). Clinical response rates were lower in men than women, esp. with Moxi (86% men, 94% women; stats NA). Clinical response rates were highest in ≥65 yo age group (95%, stats NA). Clinical response rates with Ceph were approx. equivalent for spontaneous infections and those occurring with a wound while, for Moxi, rates were higher for infections occurring with a wound (96% vs. 87%, stats NA).
Bact. eradication/presumed eradication rates at 7–21 days after the end of therapy were 91% in both groups (stats NA). For S. aureus, eradication rates were 92% (Moxi) and 93% (Ceph) (stats NA) while for Streptococcus species they were 90% (Moxi) and 82% (Ceph) (stats NA).AE profiles for the 2 drugs were similar (stats NA).AEs occurred in 21% of Moxi and 19% of Ceph patients. 9 AEs were serious/life-threatening in 7 patients (1 with Moxi, 6 with Ceph).AEs led to premature study D/C in 13 patients (6 Moxi, 7 Ceph). Majority of AEs were referable to GI tract and skin and frequencies/types were similar in the 2 groups.
(2) MC/R/DB/PG 191/100 Moxi 400 mg PO qd × 5–14 days Clin. cure or improvement occurred in 93% of patients in both groups. Bact. eradication/presumed eradication occurred in 89% (Moxi)
194/112 Ceph 500 mg PO tid × 5–14 daysb and 94% (Ceph) of patients. Eradication rates for S. aureus were 92% (Moxi) and 89% (Ceph), No mention was made of AEs and results of statistical analyses NA.
(3) MC/R/DB/PG 21/18 Moxi 200 mg PO qd × 5–14 days Clin. cure or improvement occurred in 95% (Moxi 200), 100% (Moxi 400), and 89% (Ceph) of patients. Corresponding bact. eradication/
22/15 Moxi 400 mg PO qd × 5–14 days presumed eradication rates were 72%, 80%, and 80%. Predominant pathogens were S. aureus (37.5%), S. haemolyticus (18.8%), and E. faecalis
26/15 Ceph 500 mg PO tid × 5–14 days (10.4%). All treatments were “well-tolterated” with “similar frequencies of drug-related AEs”. Results of statistical analyses NA.
Complicated SSSIs
(4) MC/R/DB/PG (North America) 162/NA Moxi IV → PO (total of 7–14 days) Clin. cure or improvement occurred in 77.2% of Moxi and 81.5% of β-lactam comparator recipients (p=NS).
173/NA β-lactam/β-lactamase inhibitor IV → PO (total of 7–14 days)
Complicated SSSIs
MC/R/PG (International) 315/NA Moxi 400 mg IV → PO qd × 7–21 days Clin. cure or improvement occurred in 80.6% of Moxi and 84.5% of β-lactam comparator recipients (p=NS).
317/NA β-lactam/β-lactamase inhibitor IV → PO (total of 7–21 days)
Pooled results (stats NA)
Surgical I + D or debridement occurred in 55% of Moxi and 53% of β-lactam comparator subjects. Success rates varied by diagnosis (61% in infected skin ulcers to 90% in complicated erysipelas). Clin. cure or improvement by pathogen was as follows:
S. aureusc: Moxi 82.2%, Comparator 87.6% E. coli: Moxi 81.6%, Comparator 84.8% K. pneumoniae: Moxi 91.7%, Comparator 70.0% E. cloacae: Moxi 81.8%, Comparator 57.1%
(5) MC/R/DB/PG 180/119 Moxi 400mg IV → PO (total of 7–14 days) Clin. cure rates 10–42 days post-therapy were 79% (Moxi) and 82% (Pip-Tazo → Amox-Clav) (p=NS). Clin. cure rates were similar by
187/119 Pip-Tazo 3.375 g IV qd → Amox-Clav PO 800 mg bid (total of 7–14 days) infection type in the 2 groups except abscess (79% Moxi vs. 93% Pip-Tazo → Amox-Clav, p=0.04). Univariate followed by multivariate regression analysis identified the no. of surgeries (ie, ≥2) as being an independent risk factor for
minimum duration of IV therapy was 3 days. failure of abscess cure.After adjusting for risk factors for failure of abscess cure, the difference between groups disappeared (odds ratio, 1.05; p=0.12).There were no significant differences between the groups in bacteriologic eradication rates by organism or for monomicrobial or polymicrobial infections.AE rates were comparable in the 2 groups (drug-related AEs in 31% and 30% of Moxi and Pip-Tazo → Amox-Clav patients, respectively; corresponding rates of diarrhea were 5% and 8%, and nausea were 4% and 2%; premature D/C for drug-related AEs in 14 and 17 patients). Drug-related serious AEs with Moxi included weakness, worsening of drug reaction rash, cellulitis exacerbation, PMC, and clinical failure and with Pip-Tazo → Amox-Clav included cardiopulmonary arrest, worsening CHF, allergic reaction, asthenia, worsened skin eruption, allergic reaction, persistent right leg abscess, bloody diarrhea, osteomyelitis, and clinical failure.
a

Note:Clinically/bacteriologically;

b

Could add metronidazole 400 mg tid for anaerobic coverage;

c

Methicillin-suspectible strains.

Abbreviations: AE, adverse event;Amox-Clav, amoxicillin-clavulanate; Ceph, cephalexin; CHF, chronic heart failure; DB, double-blind; D/C, discontinuation; GI, gastrointestinal; IV, intravenous; I + D, incision + drainage; MC, multicenter; Moxi, moxifloxacin; NA, not available; NS, non-significant; PG, parallel group; R, randomized; qd, once daily; tid, thrice daily; Pip-Tazo, piperacillin-tazobactam; PMC, pseudomembrous colitis; PO, oral.