TABLE 7.6.

Results of clinical trials involving trovafloxacin

Author (reference)	Design	n ()	Indication	Regimen	Duration	Results
Respiratory tract infections
						End of treatment success*
Niederman et al (186) (Abst)	Prospective, randomized, double-blind	433 (362)	Community-acquired pneumonia	A: 200 mg iv every day followed by T 200 mg oral every day	7 to 14 days	A/T: 160/178 (90%)
				Ceft: 1 g iv every day followed by cefpo 200 mg oral bid (erythro iv or oral could be added here if atypical pneumonia suspected – dose not specified)	7 to 14 days	Ceft/cefpo: 160/184 (87%) P=0.35 (regimens are “statistically equivalent”) Day 30 of study success* A/T: 137/159 (86%) Ceft/cefpo: 139/169 (82%) P=0.25 (regimens are “statistically equivalent”)
						End of treatment success*
Sullivan et al (187) (Abst)	Prospective, randomized, double-blind	359 (300)	Community-acquired pneumonia	T: 200 mg oral every day	7 to 10 days	T: 138/144 (96%)
				Clarithro: 500 mg oral bid	7 to 10 days	Clarithro: 147/156 (94%) Day 30 of study success* T: 89% Clarithro: 86% (no CI or P, but regimens are “statistically equivalent”)
						End of treatment success†
Mandell et al (188) (Abst)	Summary of six multicentre, double-blind, comparative clinical trials	257 (NA)	Community-acquired pneumonia caused by Streptococcus pneumoniae	A: 200 mg iv every day (2 trials)	7 to 14 days	A/T: 93%
				T: 200 mg oral every day (4 trials)	7 to 10 days
				C: ceft or erytho, cipro or ampi/amox, clarithro, cefaclor, amox+erythro (route not specified)	NA	C: 94%
						Day 30 of study success† A/T: 91% C: 88%
						End to treatment success*
Graham et al (189) (Abst)	Prospective, randomized, Double-blind	267 (191)	Nosocomial pneumonia	A: 300 mg iv every day followed by T 200 mg oral every day	10 to 14 days	A/T: 68/88 (77%)
				Cipro: iv bid followed by oral with or without clinda or metro (no dosage given)	10 to 14 days	Cipro: 80/103 (78%)
				Aztreonam or vancomycin could be added to either group for documented Psuedomonas aeruginosa or MRSA, respectively		Day 30 of study success‡ A/T: 69% Cipro: 68% (no CI or P, but the regimens are “statistically equivalent”)
Genitourinary tract infections
						At 5- to 9-days post-treatment
Hook et al (205)	Prospective, randomized, open, noncomparative, dose ranging study	39 (31)	Uncomplicated gonorrhea	T: 50 mg oral single dose (n=9) T: 100 mg oral single dose (n=12) T: 200 mg oral single dose (n=10)	Single dose	T: 100% cure for all three regimens (as defined by post-treatment culture results)
						5- to 9-day post-treatment success‡
Jones et al (206)	Prospective, randomized, double-blind	625 (394 clinically evaluable)	Uncomplicated gonococcal urethritis or cervicitis	T: 100 mg oral single dose	Single dose	T: 174/182 (96%)
				Oflox: 400 mg oral single dose	Single dose	Oflox: 208/212 (98%) The regimens produced an “equivalent” clinical response (95% CI calculated, but not reported); P not reported

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 who received the treatment or had the condition.

^*Success defined as cure (resolution of baseline signs and symptoms) or improvement (partial resolution and no further antibiotic therapy required).

^†Definition of success (clinical efficacy) was not provided;

^‡Success defined as cure (complete resolution of signs and symptoms) or improvement (incomplete resolution). A Alatrofloxacin; Amox Amoxicillin; Ampi/amox Ampicillin/amoxicillin; C Comparators; Ceft Ceftriaxone; Cefpo Cefpodoxime; Cipro Ciprofloxacin; Clarithro Clarithromycin; Clinda Clindamycin; Duration Length of treatment Erythro Erythromycin; iv Intravenous; Metro Metronidazole; MRSA Methicillin-resistant Staphylococcus aureus; NA Information not available; Oflox Ofloxacin; T Trovafloxacin