Pefloxacin versus ceftazidime in the treatment of a variety of gram-negative-bacterial infections.

In a prospective open randomized trial, pefloxacin was given to 53 patients and ceftazidime was given to 50 patients suffering from bronchopneumonia (n = 29), deep soft tissue infection (n = 19), urinary tract infection (n = 28), chronic osteomyelitis in exacerbation (n = 15), chronic otitis media in exacerbation (n = 3), malignant external otitis (n = 3), abdominal abscess (n = 2), septic arthritis (n = 1), acute cholangitis (n = 1), bacterial endocarditis (n = 1), and subacute sinusitis (n = 1). Underlying aggravating factors coexisted in 45 and 41 patients in the pefloxacin and ceftazidime groups, respectively, with 32 and 33 infections characterized as nosocomial and severe in each group, respectively. Pefloxacin was given at a dose of 400 mg intravenously (i.v.) (n = 16) or per os (n = 23) every 8 or 12 h, as well as i.v. followed by per os (n = 14), for 7 to 180 days; and ceftazidime was given at 2 g i.v. every 8 h (n = 45) or 1 g intramuscularly every 8 h (n = 5) for 7 to 56 days. Pseudomonas aeruginosa and various members of the family Enterobacteriaceae predominated in culture specimens. Clinical cure was observed in 38 and 39 patients given pefloxacin and ceftazidime, respectively; 10 and 7 patients were improved; and in 5 and 4 patients treatment failed. Pathogen eradication was observed in 42 and 39 patients, respectively; persistence was observed in 8 and ll patients, respectively, followed by the emergence of resistance in five and four P. aeruginosa strains, respectively (P = not significant). With the exception of photosensitivity rash in seven patients given pefloxacin, all side effects observed in eight and three patients in the pefloxacin and ceftazidime groups, respectively (P < 0.01), were not important and were self-limited. It is concluded that pefloxacin is as effective as ceftazidime in moderate to severe gram-negative-bacterial infections, with similar trends toward development of resistance during therapy.

RCT Entities:   Population Interventions Outcomes