COMPARISON OF THE EFFICACY AND SAFETY OF ISEPAMICIN AND AMIKACIN IN THE TREATMENT OF ACUTE LOWER RESPIRATORY-TRACT INFECTIONS CAUSED BY GRAM-NEGATIVE ORGANISMS

In a prospective multicentre open trial, hospitalised adult patients w ith acute lower respiratory tract infections, mainly pneumonia or bron chitis, were randomised to receive either isepamicin 8 or 15 mg/kg onc e daily depending on the severity of the infection or amikacin 7.5 mg/ kg twice daily. Patients with infections known to be caused by Pseudom onas aeruginosa were to be given concomitant treatment with ceftazidim e. In the intent-to-treat population, i.e. patients who received at le ast one dose of randomised treatment, a clinical cure or improvement a t the end of treatment was seen in 112/125 (90%) isepamicin patients a nd 55/60 (92%) amikacin patients. The corresponding rates for patients with a primary diagnosis of pneumonia were 45/52 (87%) and 25/28 (89% ). Cure/improvement rates for patients with P. aeruginosa as the causa tive pathogen (34 of whom also received ceftazidime) were 28/30 (93%) and 16/18 (89%), respectively. In the efficacy population (patients wh o had a valid pretreatment culture and who met other evaluability crit eria), total elimination (documented or presumed if infection had reso lved) of target pathogens occurred in 54/63 (86%) of isepamicin patien ts and 25/30 (83%) of amikacin patients. P. aeruginosa, Escherichia ro ll, Klebsiella pneumoniae and Staphylococcus aureus were commonly isol ated pathogens. Treatment-related adverse events were mainly mild or m oderate in severity and occurred in 10% of isepamicin patients and 13% of amikacin patients. Four patients (3 isepamicin and 1 amikacin) dis continued treatment because of severe adverse events and a further ise pamicin patient withdrew because of a mild adverse event. Nephrotoxici ty and ototoxicity occurred infrequently.