[Cefotaxime, twenty years later. Observational study in critically ill patients].

OBJECTIVE: Afer twenty years of commercial availability of cefotaxime, the objective of this study was to know the reasons and modes of use, administration dosage as well as its effectiveness and tolerance in critically ill patients admitted to Intensive Care Units (ICU) in our country.

DESIGN: Open, prospective, observational, multicenter study.

SUBJECTS: All patients who had cefotaxime administered in monotherapy or in combination with other antibiotics were included as cases in this study.

RESULTS: A total of 624 patients were included in 44 ICUs (average 14 cases). Cefotaxime was indicated for therapy of 274 community-acquired infections (43.9%), 194 prophylaxis (31.1%), and 156 nosocomial infections (25.0%). Both community-acquired pneumonia (149, 34.7%) and mechanical ventilation associated pneumonia (62, 14.4%) predominated, followed by trachebronchitis (60, 13.9%) and central nervous system infections (42, 9.8%). Over half of infections (222, 51.6%) presented as systemic inflammatory response syndrome (SIRS), 133 (30.9%) as severe sepsis, and 75 (17.4%) as septic shock. In 374 (87.0%) out of the 430 cases of infection treatment, cefotaxime wan prescribed on an empirical basis and in 150 of them (40.1%) a further confirmation of the causative agent was obtained. In 120 (27.9%) cases, cefotaxime was administered as monotherapy and in the remaining cases in association with one or more antibiotics.The use of cefotaxime as prophylaxis was evaluated as failure in 31 (16.0%) of the cases, whereas in treatment it was considered as failure in 98 (22.8%) of the 430 cases, 51 community-acquired infections, 27 (27.3%) of ICU-acquired infections, and 20 (35.1%) nosocomial infections acquired outside the ICU. In 127 (29.5%) of the 430 infection treatments the initial treatment was changed. The reasons for the change included clinical failure (36, 28.3%), recovery of an uncovered pathogen with the antibiotic (40, 31.5%), emergence of multi-resistant pathogens (28, 22.0%), to decrease the therapeutic spectrum (7, 5.5%), and other reasons (16). Cefotoxime was also changed in 21 (6.0%) of the 194 cases in which it was used as prophylaxis. In 32 (5.1%) patients 37 adverse effects were noted which were associated with a possible or likely use of cefotaxime. Most notably, diarrhoea in 15 (2.4%) occasions and skin rash in 6 cases (1.0%).

CONCLUSIONS: Cefotaxime is still one of the therapies of choice for community-acquired and nosocomial infections as well as in different prophylactic modes. It is mostly used on an empirical basis and associated with other antibiotics. Clinical and microbiological efficiency is high whereas adverse effects related to its use have been scarce.