Prospective, randomized comparison of sequential intravenous followed by oral ciprofloxacin with intravenous ceftazidime in the treatment of serious infections.

In a prospective, comparative trial, 47 hospitalized patients with serious infections that required parenteral antibiotic therapy were randomly assigned to receive either ciprofloxacin (200 mg every 12 hours intravenously followed by 500 mg every 12 hours orally at a time dependent on the patients' clinical and bacteriologic responses) or ceftazidime (2 g every eight to 12 hours intravenously). All evaluable subjects (39 patients) had documented infections, 23 percent of which were associated with bacteremia. The mean/median duration of intravenous antibiotic use for ciprofloxacin was 7.37/five days and for ceftazidime 9.95/seven days; 63 percent of the ciprofloxacin patients received an additional 17 days of oral therapy with ciprofloxacin, whereas intravenous therapy with ceftazidime was followed by an average of 12 days of an oral regimen in 55 percent of patients. Overall response rates for patients receiving ciprofloxacin and ceftazidime were 76 percent (16 of 21) and 82 percent (18 of 22), respectively. Four out of five bacteremias in each group were successfully treated. Overall, 69 percent of the pathogens were gram-negative aerobes, and 47 percent of the infections involved the urinary tract. Failure of therapy was most often associated with pneumonia (two of five failures with ciprofloxacin and three of four failures with ceftazidime). Adverse effects occurred in approximately 20 percent of patients in each group and were mild and reversible. Superinfections occurred in five of 19 (26 percent) ciprofloxacin recipients and seven of 20 (35 percent) ceftazidime recipients. All fungal superinfections involved the genitourinary tract and occurred most often in association with chronic indwelling catheters. Enterococcal superinfections occurred in both groups (a bacteremic urinary tract infection in a ceftazidime patient and osteomyelitis in a ciprofloxacin patient). Clostridium difficile-associated diarrhea was documented in a ceftazidime recipient. The mean duration of hospitalization following the onset of antibiotic treatment was 10.45 days in the ciprofloxacin group and 12.95 days in the ceftazidime group. Sequential intravenous/oral ciprofloxacin was as safe and effective as intravenous ceftazidime in the treatment of infections due to susceptible gram-positive and gram-negative organisms.

RCT Entities:   Population Interventions Outcomes