Multicenter, phase IV evaluation of intravenous ciprofloxacin as initial therapy in patients with lower respiratory tract, urinary tract, and skin/skin structure infections

• Published in: Clinical therapeutics 1995-05, Vol.17 (3), p.353-365
• Main Author: PANKEY, G. A
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - adverse effects; Anti-Infective Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Ciprofloxacin - administration & dosage; Ciprofloxacin - adverse effects; Ciprofloxacin - therapeutic use; Female; Humans; Injections, Intravenous; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Prospective Studies; Respiratory Tract Infections - drug therapy; Respiratory Tract Infections - microbiology; Skin Diseases, Infectious - drug therapy; Skin Diseases, Infectious - microbiology; Urinary Tract Infections - drug therapy; Urinary Tract Infections - microbiology
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/0149-2918(95)80101-4

A prospective, open-label, multicenter, Phase IV study of the efficacy and safety of intravenous (IV) ciprofloxacin (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 (94%) patients and failure was reported in 23 (6%) patients. Of 330 patients valid for investigation 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.