TABLE 7.3.
Results of clinical trials involving grepafloxacin
| Author (reference) | Design | n () | Indication | Regimen | Duration | Results |
|---|---|---|---|---|---|---|
| Respiratory tract infections | ||||||
| 3- to 5-day post-treatment success rates* | ||||||
| Chodosh et al (162) | Prospective, randomized, double-blind | 624 (467) | Acute bacterial exacerbations of chronic bronchitis | G: 400 mg oral every day (n=151) | 10 days | G (400 mg): 140/151 (93%) [95% CI=–4.5% to 8.9%] (Clinically, G regimen is “as effective” as ciprofloxacin regimen)† |
| G: 600 mg oral every day (n=156) | 10 days | G (600 mg): 137/156 (88%) [95% CI=–10.0% to 4.4%] (Clinically, G regimen is “as effective” as ciprofloxacin regimen)† | ||||
| Ciprofloxacin: 500 mg oral bid (n=160) | 10 days | Ciprofloxacin: 146/160 (91%) | ||||
| 14- to 28-day post-treatment success rates‡ | ||||||
| G (400 mg): 124/143 (87%) [95% CI=–1.7% to 15.4%] (Clinically, G regimen is “as effective” as ciprofloxacin regimen)† | ||||||
| G (600 mg): 122/151 (81%) [95% CI=–7.5% to 10.3%] (Clinically, G regimen is “as effective” as ciprofloxacin regimen)† | ||||||
| Ciprofloxacin: 123/154 (80%) | ||||||
| 14-day post-treatment success rates* | ||||||
| Langan et al (163) | Prospective, randomized, double-blind | 656 (611) | Acute bacterial exacerbations of chronic bronchitis | G: 400 mg oral every day (n=202) | 7 or 10 days | G (400 mg): 165/202 (82%) [95% CI=–9.5% to 4.6%] (Clinically, G regimen is “as effective” as amoxicillin regimen)† |
| G: 600 mg oral every day (n=206) | 7 or 10 days | G (600 mg): 175/206 (85%) [95% CI=–6.2% to 7.5%] (Clinically, G regimen is “as effective” as amoxicillin regimen)† | ||||
| Amoxicillin: 500 mg oral tid (n=203) | 7 or 10 days | Amoxicillin: 172/203 (85%) | ||||
| Clinical efficacy§ | ||||||
| Kobayashi et al (164) (Abst) | Double-blind | 203 (190) | Chronic bronchitis (n=90), bronchiectasis with infection (n=53), diffuse panbronchiolitis (n=6), secondary infection with chronic respiratory disease (n=41) | G: 300 mg oral every day | 14 days | G: 84/93 (90%) |
| Oflox: 200 mg oral tid | 14 days | Oflox: 88/97 (91%) | ||||
| [90% CI=–6.3% to 7.6%] (G regimen is “equivalent” to oflox regimen in “clinical usefulness”)† | ||||||
| 28- to 42-day post-treatment success rates* | ||||||
| O’Doherty et al (165) | Prospective, randomized, double-blind | 264 (225) | Community-acquired pneumonia | G: 600 mg oral every day | 7 or 10 days | G: 87/114 (76%) |
| [95% CI=–12% to 10%] (Clinically, G regimen “is equivalent” to amoxicillin regimen)† | ||||||
| Amoxicillin: 500 mg oral tid | 7 or 10 days | Amoxicillin: 85/111 (77%) | ||||
| Patel et al (166) (Abst) | Prospective, randomized, double-blind | 494 (419) | Community-acquired pneumonia | G: 600 mg oral every day | 10 days | G: 175/211 (83%) cure¶ |
| Clarithro: 250 mg oral bid | 10 days | Clarithro: 184/208 (88%) cure¶ (regimens are “equivalent” by a 95% CI calculation, not provided) † | ||||
| Clinical efficacy§ | ||||||
| Kobayashi et al (167) (Abst) | Double-blind | NA (225) | Bacterial pneumonia (n=195), mycoplasma pneumonia (n=27), chlamydia pneumonia (n=3) | G: 300 mg oral every day | 14 days | G: 108/112 (96%) |
| Oflox: 200 mg oral tid | 14 days | Oflox: 105/113 (93%) [90% CI=–2.3% to 7.5%] (G regimen is “equivalent” to oflox regimen in “clinical usefulness”)† | ||||
| Genitourinary tract infections | ||||||
| At 5 to 10 days post-treatment | ||||||
| Hook et al (191) | Randomized, open | 351 (299) all males | Uncomplicated gonorrhea | G: 400 mg oral single dose | Single dose | G: 147/149 (99%) cure** |
| Cefixime: 400 mg oral single dose | Single dose | Cefixime: 145/150 (97%) cure** | ||||
| Clinical efficacy§ | ||||||
| Matsuda et al (192) (Abst) | Double-blind | 244 (201) | Intrauterine infection (n=83), adnextis (n=63), bartholinitis (n=1), Bartholin’s abscess (n=54) | G: 300 mg oral every day | 7 days | G: 98/100 (98%) |
| Oflox: 200 mg oral tid | 7 days | Oflox: 94/101 (93%) | ||||
| [90% CI=–0.8% to 8.7%] (regimens are “equivalent” in “clinical usefulness”)† | ||||||
| Mroczkowski et al (193) | Open, noncomparative, dose ranging study | 25 (21) all females | Chlamydia trachomatis infection | G: 400 mg oral every day | 7 days | C trachomatis culture was negative at follow-up for all patients (100% cure) (21–28 days) |
| Skin and skin structure infections | ||||||
| Clinical efficacy§ | ||||||
| Arata et al (207) (Abst) | Double-blind | 227 (209) | Furuncle, furunculosis, carbuncle, cellulitis, erysipelas | G: 200 mg oral every day | 7 days | G: 95/105 (90%) |
| Oflox: 200 mg oral tid | 7 days | Oflox: 92/104 (88%) (regimens reported to be “equivalent”, a CI was not provided)† | ||||
n () Number of patients (number of patients with complete data at the end of treatment or at follow-up if there was no evaluation at the end of treatment). Where n appears under regimen or indication, it refers to the number of clinically evaluable patients that received the treatment or had the condition.
*
Success defined as cure (complete resolution of signs and symptoms of acute infection) or improvement (a reduction in the severity or number of signs and symptoms).
†
P not reported.
‡
Success defined as persistent resolution (condition is as good or better than at the end of treatment) or mild relapse (not quite as good as at the end of treatment).
§
Clinical efficacy not defined.
¶
Clinical cure not defined.
**
Cure defined as microbiological eradication. Clarithro Clarithromycin; Duration Length of treatment; G Grepafloxacin; Oflox Ofloxacin