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Abstract
A prospective, open-label, multicenter, Phase IV study of the efficacy and safety
of intravenous (IV) ciprofloxin (400 mg by 60-minute infusion every 12 hours) in the
treatment of lower respiratory tract infections (LRTIs), urinary tract infections
(UTIs), and skin/skin structure infections (SSSIs) in hospitalized patients was conducted
in 1991. After a minimum of 3 days of IV therapy, patients could be switched to oral
therapy with any antimicrobial. Of 360 patients who were valid for investigator assessment
of clinical outcome at the end of IV therapy, a favorable outcome (cure and improvement
in infection) was reported in 337 (84%) patients and failure was reported in 23 (6%)
patients. Of 330 patients valid for investigator assessment of clinical outcome at
the end of all therapy (IV treatment alone or IV treatment followed by an oral antimicrobial),
a favorable outcome was noted in 311 (94%) patients, and failure occurred in 19 (6%)
patients. Adverse events were noted in 72 (9%) of 782 patients and led to premature
discontinuation of IV therapy in 23 (3%) patients. IV ciprofloxacin appears to be
effective and safe in the management of mild-to-moderate LRTI and SSSI and mild, moderate,
or severe UTI in hospitalized patients.
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© 1995 Published by Elsevier Inc.
