[Comparative study of intravenous ceftriaxone followed by oral cefixime versus ceftriaxone alone in the treatment of severe upper urinary tract infections]

Abstract

Cefixime is a new orally active cephalosporin. Its MICs and beta-lactamase stability are similar to those of the parenteral third generation cephalosporins. This trial was conducted to determine the effectiveness and safety of ceftriaxone as compared with a treatment where oral cefixime was given after a 4-day treatment with ceftriaxone in severe upper urinary tract infections usually requiring parenteral treatment during two weeks. In an open, controlled trial, 95 patients met the inclusion criteria; 48 received IV ceftriaxone 2 g daily during 4 days, followed by IM or IV ceftriaxone 1 g daily for 11 days; 47 patients were treated by IV ceftriaxone 2 g.o.d. during 4 days and then by oral cefixime 200 mg b.i.d. for 11 days. Clinical cure at the end of treatment was achieved in 44 patients in the cefixime group and 47 patients of the ceftriaxone group. Ten to 84 days after the end of treatment, the overall clinical cure and bacteriologic eradication rates for these patients were 74.3 per cent (29/39) for cefixime and 81 per cent (34/42) for ceftriaxone. Treatment failure occurred in two patients in the cefixime arm, one in a patient with renal atrophy and vascular stenosis and the other in an 86-year old diabetic and bed-ridden woman with an infection following the use of a urinary catheter. There were eight relapses or re-infections (about 20 per cent) in each group. Seven minor adverse events were seen in six patients treated with ceftriaxone: pain upon IM injection (3 cases), diarrhea (2 cases) associated in one case with a generalized rash for which treatment was discontinued, and nausea (one case). Laboratory changes in both groups were not noteworthy and without clinical relevance. These results suggest that it seems possible to propose new parenteral cephalosporins with conversion to the oral route on the 5th day using the same class of drugs in the treatment of severe upper urinary tract infections, excluding certain urological or vascular underlying conditions and provided that duration of treatment is adapted to the type of clinical setting. These data define more accurately the use of cefixime with respect to currently available drugs.