TABLE 7.5.
Results of clinical trials involving sparfloxacin
| Author (reference) | Design | n () | Indication | Regimen | Duration | Results |
|---|---|---|---|---|---|---|
| Respiratory tract infections | ||||||
| DeAbate et al (177) (Abst) | Prospective, randomized, double-blind | 798 (504) | Acute bacterial exacerbations of chronic bronchitis | S: 400 mg oral on day 1 then 200 mg oral every day | 10 days | S: 216/253 (85%) success* |
| Oflox: 400 mg oral every 12 h | 10 days | Oflox: 223/251 (89%) success* [95% CI −9.3% to 2.4%] (regimens are “statistically equivalent”)† | ||||
| End of treatment success‡ | ||||||
| Allegra et al (178) | Prospective, randomized, double-blind | 734 (351) | Acute exacerbations of chronic obstructive pulmonary disease | S: 200 mg oral on day 1 then 100 mg oral every day | Mean of 10 days | S: 151/173 (87%) |
| Amox/clav: 500/125 mg oral tid | Mean of 10 days | Amox/clav: 158/178 (89%) | ||||
| [90% CI=–4.2% to 7.2%] (The S regimen is “as effective” as the amox/clav regimen)† | ||||||
| 10 day post-treatment success rates‡ S: 129/164 (79%) Amox/clav: 130/163 (80%) [90% CI=–6.3% to 8.5%] (The S regimen is “as effective” as the amox/clav regimen)† |
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| Overall efficacy | ||||||
| Taytard et al (179) (Abst) | Prospective, randomized, double-blind | NA (201) | Acute bacterial exacerbations of chronic bronchitis | S: 400 mg oral on day 1 then 200 mg oral every day | 5 days | S: 86% |
| Amox/clav: 500/125 mg tid | 10 days | Amox/clav: 85% (a statistical analysis of these results was not provided) † | ||||
| End of treatment success§ | ||||||
| Lode et al (180) | Prospective, randomized, double-blind | 808 (620) | Community-acquired pneumonia | S: 400 mg oral on day 1 then 200 mg oral every day | Mean of 9.5 days | S: 269/310 (87%) |
| Amox/clav: 500/125 mg oral tid | Mean of 9.5 days | Amox/clav: 121/152 (80%) [90% CI=−13.4% to −0.9%] (The S regimen is “at least as effective” as the amox/clav regimen) † | ||||
| Erythro: 1 g oral bid | Mean of 9.5 days | Erythro: 135/158 (85%) [90% CI=–6.9% to 4.3%] (The S regimen is “at least as effective” as the erythro regimen) † | ||||
| 42 day post-treatment success rates§ S: 239/285 (84%) Amox/clav: 104/139 (75%) [90% CI=−16% to −2%] (The S regimen is “at least as effective” as the amox/clav regimen)† Erythro: 109/132 (83%) [90% CI=–7.8% to 5.2%] (The S regimen is “at least as effective” as the amox/clav regimen)† |
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| Bensch et al (181) (Abst) | Prospective, randomized, double-blind | 428 (338) | Community-acquired pneumonia | S: 400 mg oral on day 1 then 200 mg oral every day | 10 days | S: 153/177 (86%) success¶ |
| Erythro: 500 mg oral every 6 h | 10 days | Erythro: 130/161 (81%) success¶ [95% CI=–2.2% to 13.6%] (regimens are “statistically equivalent”)† |
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| Donowitz et al (182) (Abst) | Prospective, randomized, double-blind | 330 (262) | Community-acquired pneumonia | S: 400 mg oral on day 1 then 200 mg oral every day | 10 days | S: 116/134 (87%) success¶ |
| Cefaclor: 500 mg oral every 8 h | 10 days | Cefaclor: 108/128 (84%) success¶ [95% CI=–6.3% to 10.7%] (regimens are “statistically equivalent”)† |
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| 4- to 7-day post-treatment success§ | ||||||
| Ortqvist et al (183) | Prospective, randomized, double-blind | 304 (264) | Community-acquired pneumonia | S: 400 mg oral on day 1 then 200 mg oral every day | Mean of 10.2 days | S: 124/131 (95%) |
| ROXI: 150 mg oral bid | Mean of 10.1 days | ROXI: 106/133 (80%) [90% CI=−21.5% to −8.4%] (“sparfloxacin was superior”)† |
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| 42-day post-treatment success§ S: 121/129 (94%) ROXI: 103/131 (79%) [90% CI=−22.0% to −8.3%] (“sparfloxacin was superior”)† |
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| End of treatment success** | ||||||
| Portier et al (184) | Prospective, randomized, double-blind | 213 (167) | Community-acquired pneumonia | S: 400 mg oral on day 1 then 200 mg oral every day | Mean of 10 days | S: 79/86 (92%) |
| Amox/oflox: amox 1 g oral tid and oflox 200 mg oral bid | Mean of 10 days | Amox/oflox: 66/81 (81%) | ||||
| [90% CI=−19% to −1.8%] (The S regimen is “at least as effective” as the amox/oflox regimen)† 30 day post-treatment success rates** S: 69/79 (87%) Amox/oflox: 61/78 (78%) [90% CI=–19% to 0.7%] (The S regimen is “at least as effective” as the amox/oflox regimen)† |
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| End of treatment success†† | ||||||
| Aubier et al (185) | Prospective, randomized, double-blind | 329 (286) | Community-acquired pneumonia | S: 400 mg oral on day 1 then 200 mg oral every day | Mean of 10.8 days | S: 125/136 (92%) |
| Amox: amox 1 g oral tid | Mean of 10.8 days | Amox: 131/150 (87%) [90% CI=–10.5% to 1.3%] (The S regimen is at least “as effective” as the amox regimen)† 39 to 41 day post-treatment success†† S: 112/126 (89%) Amox: 118/140 (84%) [90% CI=–11.4% to 2.2%] (The S regimen is at least “as effective” as the amox regimen)† |
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| Genitourinary tract infections | ||||||
| Less than 15 day post-treatment success‡‡ | ||||||
| Moi et al (198) | Prospective, randomized, double-blind | 238 (184) all males | Acute gonococcal urethritis | S: 200 mg oral single dose | Single dose | S: 95/96 (99%) |
| Cipro: 250 mg oral single dose | Single dose | Cipro: 86/88 (98%) [90% CI=–4.4% to 1.9%] (regimens are “equally effective”)† |
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| 2- to 5-day post-treatment success§§ | ||||||
| Phillips et al (199) | Prospective, randomized, double-blind | 725 (608) all males | Nongonococcal urethritis | S: 200 mg oral on day 1 then oral 100 mg every day | 3 days | S (3 day): 159/195 (82%) |
| S: 200 mg oral on day 1 then 100 mg oral every day | 7 days | S (7 day): 161/201 (80%) | ||||
| Doxy: 200 mg oral every day | 7 days | Doxy: 174/212 (82%) | ||||
| 14 to 18 day post-treatment success¶¶ S (3 day): 113/186 (61%) S (7 day): 112/183 (61%) Doxy: 121/196 (62%) (90% CI were calculated but not given. Overall success was “statistically equivalent” between groups)† |
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| 4- to 14-day post-treatment success*** | ||||||
| Naber et al (200) | Prospective, randomized, double-blind | 686 (477) | Complicated urinary tract infection | S: 200 mg oral on day 1 then 100 mg oral every day | Mean of 11 days | S: 166/235 (71%) |
| Cipro: 500 mg oral bid | Mean of 11 days | Cipro: 187/242 (77%) [90% CI=0.04% to 13.23%] (The groups “differ” with cipro being superior) † 15 to 56 day post-treatment success*** S: 148/247 (60%) Cipro: 158/239 (66%) [90% CI=–1.0% to 13.4%] (The groups “differ” with cipro being superior)† “Clinical results” were “equivalent” between groups† |
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| Iravani et al (201) (Abst) | Prospective, randomized, double-blind | 1175 (978) all females | Acute uncomplicated urinary tract infection | S: 400 mg oral single dose | Single dose | S (1 day): 335/360 (93%) success¶ [95% CI=−0.2% to 9.1%] |
| S: 400 mg oral on day 1 then 200 mg oral every day | 3 days | S (3 day): 328/355 (92%) success¶ [95% CI=–0.9% to 8.5%] |
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| Cipro: 250 mg oral every 12 h | 7 days | Cipro: 233/263 (89%) success¶ | ||||
| Henry et al (202) (Abst) | Prospective, randomized, open label, observer blind | 419 (383) | Acute uncomplicated urinary tract infection | S: 400 mg oral on day 1 then 200 mg oral every day | 3 days | S: 173/187 (93%) success¶ |
| Oflox: 200 mg oral every 12 h | 3 days | Oflox: 185/196 (94%) success¶ [95% CI=–6.8% to 3.1%] |
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| Clinical efficacy††† | ||||||
| Kawada et al (203) (Abst) | Prospective, open, noncomparative | 712 (712) | Uncomplicated UTI (n=79), complicated UTI (n=260), urethritis (n=315), prostatitis (n=58) | S: 100 to 300 mg oral every day | 3 to 14 days | Uncomplicated UTI: 79/79 (100%) Complicated UTI: 168/260 (65%) Urethritis: 293/315 (93%) Prostatitis: 46/58 (79%) |
| Clinical efficacy‡‡‡ | ||||||
| Matsuda et al (204) (Abst) | Prospective, open, noncomparative | 201 (201) | Adnexitis (n=31), endometritis (n=85), cervicitis (n=45), other (n=40) | S: 200 to 300 mg oral every day or bid | 7 days | Adnexitis: 30/31 (97%) Endometritis: 80/85 (94%) Cervicitis: 44/45 (98%) Others: 40/40 (100%) |
| Skin and skin structure infections | ||||||
| Clinical success‡ | ||||||
| Lipsky et al (210) (Abst) | Prospective, randomized, double-blind | 603 (475) | Skin and skin structure infections | S: 400 mg oral on day 1 then 200 mg oral every day | 10 days | S: 90% |
| Cipro: 750 mg oral every 12 h | 10 days | Cipro: 87% [95% CI=–2.8% to 8.6%] (regimens are “statistically equivalent”)† |
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| Clinical efficacy§§§ | ||||||
| Takahashi et al (211) (Abst) | Prospective, open, noncomparative | 179 (179) | Various (folliculitis, furuncle, impetigo, erysipelas, subcutaneous abscess plus many others) | S: 100 or 200 mg oral every day or bid | 7 or 10 days | S: 155/179 (87%) |
| Clinical efficacy‡‡‡ | ||||||
| Watanabe et al (212) (Abst) | Prospective, open, noncomparative | 82 (82) | Various (infected atheroma, wound infection, cellulitis and others) | S: 200 mg oral every day or 300 mg oral every day or 150 mg oral bid | 4 to 12 days | S: 71/82 (87%) |
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 or improvement with eradication or presumed eradication.
P not reported.
Success defined as cure (return to normal of evaluated symptoms) or improvement (decrease in evaluated symptoms);
Success defined as cure (complete resolution of signs and symptoms) and resolution or improvement on chest radiography or clinical improvement (incomplete resolution) and resolution on chest radiography.
Success defined by clinical response.
Success defined as clinical cure (apyrexia plus resolution of all signs and symptoms) and resolution or improvement of radiographic signs, or as clinical improvement (apyrexia plus improvement of signs and symptoms) with resolution or improvement of radiographic signs.
Success defined as radiographic resolution or improvement and clinical cure (absence of baseline symptoms), or radiographic resolution and clinical improvement (absence of chills and fever).
Success defined as eradication of Neisseria gonorrhoeae, clinical cure or improvement (disappearance or improvement of symptoms) and less than 10 polymorphonuclear neutrophils (PMNs) per field (magnification ×1000).
Success defined as clinical cure or clinical improvement less than or equal to 5 PMNs (magnification ×1000), plus the abscence of Chlamydia trachomatis.
Success defined as clinical cure less than or equal to 10 PMNs (must be fewer than at end of treatment visit) and abscence of C trachomatis.
Success defined as overall efficacy based on clinical efficacy (resolution of symptoms present at inclusion into study) and bacteriological efficacy (eradication of initial pathogen).
Clinical efficacy evaluated based on changes in symptoms.
Clinical efficacy was rated as “excellent” or “good”, based on findings before and after treatment.
Clinical efficacy was rated as “excellent” or “good”, based on clinical and bacteriological response pre- and post-treatment. Amox Amoxicillin; Amox/clav Amoxicillin/clavulanic acid; Amox/oflox Amoxicillin/ofloxacin; Cipro Ciprofloxacin; Doxy Doxycycline; Duration Length of treatment; NA Information not available; Oflox Ofloxacin; ROXI Roxithromycin; S Sparfloxacin; UTI Urinary tract infection