A randomized study of imipenem compared to cefotaxime plus piperacillin as initial therapy of infections in granulocytopenic patients
- 1 November 1995
- journal article
- clinical trial
- Published by Springer Nature in Infection
- Vol. 23 (6) , 349-355
- https://doi.org/10.1007/bf01713564
Abstract
The objective of the presented, randomized study was to compare the efficacy of antimicrobial monotherapy with imipenem (3×0.5g/d) to a combination therapy with cefotaxime (3×2g/d) plus piperacillin (3×4g/d) for empirical treatment of infections in neutropenic patients. In 165 patients, 237 infectious episodes were evaluable. The overall response rate of patients treated with cefotaxime plus piperacillin was 67/115 (58%), of those treated with impienem 66/122 (54%). In patients not responding to the initial therapy regimen within 2 or 3 days, the antimicrobial therapy was modified. After therapy modification 85/100 patients were cured. Fever of unknown origin (FUO) showed the most favourable course compared to other infection types, with a response in 46/59 (78%) and in 35/50 (70%) cases, respectively. In comparison, pneumonias were successfully treated in only 3/21 (14%) and 7/37 (19%) cases. Even including patients with modified therapy, only 66% (21/32) of pneumonia episodes responded. The unfavourable results in pneumonias is mainly due to the high rate of 13 systemic mycoses in this group (22%). Overall, a similar response was observed in patients treated with cefotaxime plus piperacillin in comparison with imipenem. In primary bacteremias however, an advantage was observed in patients treated with imipenem (20/27; 74%) compared with cefotaxime plus piperacillin (11/23; 48%). Ziel der vorliegenden prospektiven, randomisierten Studie war der Vergleich der Effektivität einer Monotherapie mit Imipenem (3×0,5g/Tag) gegenüber einer Kombinationstherapie mit Cefotaxim (3×2g/Tag) plus Piperacillin (3×4g/Tag) in der Initialtherapie von Infektionen granulozytopenischer Patienten. 237 Infektionsepisoden bei 165 Patienten waren evaluierbar. Insgesamt wurde unter Cefotaxim plus Piperacillin eine Heilung in 67/115 (58%), unter Imipenem in 66/122 Episoden (54%) erzielt. Bei Nichtansprechen innerhalb von drei Tagen unter der Initialtherapie wurde die antibiotische Behandlung modifiziert. Hierdurch wurde bei weiteren 85/100 Patienten eine Heilung erreicht. Unter den verschiedenen Infektionstypen war die Ansprechrate bei Fieber unklarer Genese (FUO) am höchsten mit einem Therapieerfolg in 46/59 Episoden unter Cefotaxim plus Piperacillin (78%) sowie in 35/50 Fällen unter Imipenem (70%). Besonders ungünstig verliefen dagegen die Pneumonien mit einem Ansprechen in 3/21 (14%) bzw. in 7/37 (19%) der Fälle. Auch unter Therapiemodifikation ergab sich hier eine Ansprechrate von insgesamt lediglich 66% (21/32). Die ungünstigsten Ergebnisse bei diesem Infektionstyp sind hauptsächlich durch den hohen Anteil von 13 systemischen Pilzinfektionen bei den Pneumonien (22%) bedingt. Insgesamt zeigten sich keine signifikanten Unterschiede in der Ansprechrate unter Cefotaxim plus Piperacillin im Vergleich zu Imipenem. Bei den primären Bakteriämien zeigte sich jedoch eine höhere Ausheilungsrate unter Imipenem mit 20/27 Episoden (74%) im Vergleich zu Cefotaxim plus Piperacillin mit 11/23 (48%) Episoden.Keywords
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