Results of a prospective, randomized, double blind comparison of the efficacy and the safety of sequential ciprofloxacin (intravenous/oral)+metronidazole (intravenous/oral) with ceftriaxone (intravenous)+metronidazole (intravenous/oral) for the treatment of intra-abdominal infections

Abstract

The efficacy and the safety of sequential intravenous/oral (i.v./p.o.) ciprofloxacin (CIPX) plus i.v./p.o. metronidazole (MTR) was compared with i.v. ceftriaxone (CTRX) plus i.v./p.o. MTR in the treatment of complicated intra-abdominal infections. One hundred and forty two patients received study medications. Of these, 135 could be studied. Sixty-nine patients were randomized in the CIPX arm of the study and 66 in the CTRX arm. In the CIPX group 58 patients were switched to oral treatment and 11 patients remained in the intravenous arm. In the CTRX group 57 patients switched to oral MTR continuing i.v. CTRX and 9 patients remained in the i.v. branch. Success rates at the end of treatment in patients who switched to oral were 100% in both the CIPX group and the CTRX group. For validated patients continuing on oral, the success rates at the end of treatment were 63.6 and 33.3% in the CIPX and CTRX groups respectively. Overall success rates at the end of treatment and follow-up in all patients were 94.2% in the CIPX group and 89.4% in the CTRX group. Overall success rates at the end of treatment in patients with proven bacterial infection were 92.9% in the CIPX group and 88.3% in the CTRX group. Duration of hospitalization (days) for studied patients was 22.7±8.2 in the CIPX and 19.6±14.5 in the CTRX group. There was no statistical difference between the CIPX and CTRX groups in both the intent to treat and in the modified intent to treat populations. Conversion to oral therapy with CIPX/MTR was as effective as continued intravenous therapy with CTRX and oral MTR in those patients able to tolerate oral feeding.