Use of ciprofloxacin in the treatment of hospitalized patients with intra-abdominal infections.

Background: Numerous combination and single-agent antimicrobial regimens are available for the treatment of intra-abdominal infections. Selection of empiric agents must be directed at providing reliable activity against endotoxin-generating Escherichia coli, other gram-negative facultative bacteria, and anaerobes such as Bacteroides fragilis. Safety profiles, pharmacokinetic profiles, and cost-effectiveness must also be considered. Use of fluoroquinolones for the treatment of intra-abdominal infections has recently been advocated.

Methods: We review 2 prospective, comparative clinical trials conducted between 1992 and 2002 that evaluated the efficacy and safety of IV ciprofloxacin in patients with intra-abdominal infections. Separate pharmacoeconomic analyses conducted for each study are also reviewed.

Results: A total of 4 ciprofloxacin studies (2 clinical, 2 pharmacoeconomic) comprise the database. The combination of ciprofloxacin plus metronidazole was at least as effective as imipenem/cilastatin and clinically more effective than piperacillin/tazobactam therapy, based on clinical success end points. In 1 trial, treatment success for the clinically valid population was reported for 84% (93/111) of patients treated with IV ciprofloxacin/metronidazole, 86% (91/106) of those treated with IV/oral ciprofloxacin/metronidazole, and 81% of those treated with IV imipenem/cilastatin (91/113). The IV/oral ciprofloxacin/metronidazole regimen had a statistically significant lower mean infection-related cost than the IV only ciprofloxacin/metronidazole plus imipenem groups (difference of approximately 1100 US dollars; P = 0.029). In the second clinical trial, clinical resolution rates were statistically different for patients receiving IV/oral ciprofloxacin/metronidazole (74%) versus IV piperacillin/tazobactam therapy (63%; P = 0.047). Ciprofloxacin/metronidazole was more cost-effective compared with piperacillin/tazobactam (2200 US dollars-3600 US dollars lower cost-effective ratios per patient) regardless of whether the patient had a diagnosis of appendicitis or whether a switch to an oral drug was permissible.

Conclusions: In the studies reviewed herein, the combination of ciprofloxacin plus metronidazole was an effective and safe regimen for the treatment of intra-abdominal infections. This regimen has potential advantages over exclusively IV regimens, including the option of sequential IV/oral therapy, patient convenience, cost savings, and reduced hospital stay.