PROSPECTIVE, RANDOMIZED, CONTROLLED-STUDY COMPARING 2 DOSING REGIMENSOF GENTAMICIN ORAL CIPROFLOXACIN SWITCH THERAPY FOR ACUTE PYELONEPHRITIS/

Aminoglycosides are drugs of choice for severe gram-negative urinary t ract sepsis. Recent evidence suggests that they are just as efficaciou s, but less nephrotoxic and ototoxic, if given as a single daily dose rather than in divided doses. We considered that a single, large dose of an aminoglycoside followed by oral therapy with a different antibio tic might be equally effective and possibly less toxic. This randomize d, controlled study compared a single large i.v. dose (10 mg/kg) of ge ntamicin (S) with a standard multiple dose regimen (M) of gentamicin ( 2.5 mg/kg i.v. stat and then computer generated divided doses aiming f or peak and trough concentrations of 8 and 1.5 mg/l: respectively) for the treatment of patients with suspected acute pyelonephritis requiri ng hospitalization for parenteral antibiotic treatment. All patients w ere switched to oral ciprofloxacin either four hours after the S dose or when clinically appropriate in the M regimen. For all patients the total duration of treatment was five days. Fifty-three patients (48 wo men; mean age 32 yr) were enrolled. Clinical and bacteriological effic acy could be assessed in 41 patients. Thirteen of 16 in the S arm and 24 of 25 in the M arm were clinically cured and the other four clinica lly improved. Fifteen of 16 in the S arm and 23 of 25 in the M arm wer e cured bacteriologically (sterile urine 7-10 days after treatment). I n 41 patients high tone audiometry was carried out before or very soon after the start of treatment, and again at the end of treatment. Otot oxicity (greater than or equal to 10 dB loss in greater than or equal to 2 frequencies in both ears) was observed in 3 of 18 in the S group (17%) and 7 of 23 in the M group (30%) (NS). Other side-effects and to xicity were mild and not different between groups. Substantial cost sa vings occurred in the S group. In summary, a large single dose of gent amicin was comparable in efficacy and toxicity to a standard regimen, but cheaper and more convenient to use.