Un ensayo terapéutico aleatorizado para ceftazidima frente a ceftazidima y amikacina en pacientes granulopenicos febriles.

This is a prospective randomized study of ceftazidime alone (CAZ) vs. ceftazidime plus amikacin (CAZ-AMK) in 56 granulopenic adults (granulocyte count below 500 ul) with blood disease and with presumed or proven infections. The criteria on which antibiotics were started were fever over 38°C during at last 12 h or over 38,5°C with rigors. Eighty-one febrile episodes were evaluable. Thirty-six of these episodes were treated with CAZ alone and 45 with CAZ-AMK. Eleven other cases had to be excluded because of protocol violations. Eighty-onefebrile episodes were subdivided between sixty-five documented infections durin 44 febrile episodes (23 CAZ and 31 CAZ-AMK) and 27 cases of fever of unknown origin, FUO, (131 CAZ and 14 CAZ-AMK). Because of the discovery of non microbial causes of fever (viral 2, neoplastic 3, GVHD 1) the number of patients with FUO is 11 in the CAZ group and 10 in the CAZ-AMK group. The results were classified as follows: 1. Goos clinical response – decrease in body temperature of 2°C or temperature below 37,5°C within 72 h of beginning therapy. 2. Bacteriological response: a. sterilization of the blood b. disappearance of organism responsible for infection 3. Response of the FUO to the antibiotics 4. Relapse of fever after a good clinical response 5. Superinfections 6. Death due to infection or superinfection