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Annals of Surgery:
Original Article

Results of a Randomized Trial Comparing Sequential Intravenous/Oral Treatment with Ciprofloxacin Plus Metronidazole to Imipenem/Cilastatin for Intra-Abdominal Infections

Solomkin, Joseph S. M.D.*; Reinhart, Harald H. M.D.; Dellinger, E. Patchen M.D.; Bohnen, John M. M.D.§; Rotstein, Ori D. M.D.; Vogel, Stephen B. M.D.; Simms, H. Hank M.D.#; Hill, Carol S. R.N., M.S.N.*; Bjornson, H. Stephen M.D., Ph.D.*; Haverstock, Daniel C. M.S.; Coulter, Holly O. M.S.; Echols, Roger M. M.D.; the Intra-Abdominal Infection Study Group

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Objective: In a randomized, double-blind, multicenter trial, ciprofloxacin/metronidazole was compared with imipenem/cilastatin for treatment of complicated intra-abdominal infections. A secondary objective was to demonstrate the ability to switch responding patients from intravenous (IV) to oral (PO) therapy.

Summary Background Data: Intra-abdominal infections result in substantial morbidity, mortality, and cost. Antimicrobial therapy often includes a 7-to 10-day intravenous course. The use of oral antimicrobials is a recent advance due to the availability of agents with good tissue pharmacokinetics and potent aerobic gram-negative activity.

Methods: Patients were randomized to either ciprofloxacin plus metronidazole intravenously (CIP/MTZ IV) or imipenem intravenously (IMI IV) throughout their treatment course, or ciprofloxacin plus metronidazole intravenously and treatment with oral ciprofloxacin plus metronidazole when oral feeding was resumed (CIP/MTZ IV/PO).

Results: Among 671 patients who constituted the intent-to-treat population, overall success rates were as follows: 82% for the group treated with CIP/MTZ IV; 84% for the CIP/MTZ IV/PO group; and 82% for the IMI IV group. For 330 valid patients, treatment success occurred in 84% of patients treated with CIP/MTZ IV, 86% of those treated with CIP/MTZ IV/PO, and 81% of the patients treated with IMI IV. Analysis of microbiology in the 30 patients undergoing intervention after treatment failure suggested that persistence of gram-negative organisms was more common in the IMI IV-treated patients who subsequently failed. Of 46 CIP/MTZ IV/PO patients (active oral arm), treatment success occurred in 96%, compared with 89% for those treated with CIP/MTZ IV and 89% for those receiving IMI IV. Patients who received intravenous/oral therapy were treated, overall, for an average of 8.6 ± 3.6 days, with an average of 4.0 ± 3.0 days of oral treatment.

Conclusions: These results demonstrate statistical equivalence between CIP/MTZ IV and IMI IV in both the intent-to-treat and valid populations. Conversion to oral therapy with CIP/MTZ appears as effective as continued intravenous therapy in patients able to tolerate oral feedings.

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