Summary
In a nonblind, randomised, parallel-group study, initial empirical monotherapy with meropenem 1 g intravenously every 8 h was compared to an identical dosage of imipenem/cilastatin for the treatment of 66 febrile episodes in 61 adult neutropenic patients. 25/31 episodes treated with meropenem and 24/30 imipenem/cilastatin-treated episodes were still receiving unmodified therapy at 72 h (primary endpoint); this difference was not statistically significant. By the end of the treatment courses, 18/31 meropenem-treated episodes had responded clinically (cured or improved) compared with 18/30 episodes treated with imipenem/cilastatin. Another ten episodes initially treated with meropenem and six episodes treated with imipenem/cilastatin were cured after an additional antimicrobial agent had been administered (cured with modification). Satisfactory bacteriological responses (eradication plus presumed eradication) at the end of unmodified therapy was 9/11 in the meropenem group and 14/16 in the comparator group. Both regimes were well tolerated; however, there were more reports of nausea and/or vomiting in the imipenem/cilastatin group (7/33 vs. 2/33 in the meropenem group). The carbapenems meropenem and imipenem/cilastatin appear to be suitable agents for empirical monotherapy of febrile episodes in neutropenic patients. Meropenem may be better tolerated than imipenem/cilastatin, allowing optimal dosing in this patient population.
Zusammenfassung
In einer offenen, randomisierten Vergleichsstudie wurde die initiale empirische Monotherapie mit Meropenem in einer Dosierung von 3 × 1g täglich verglichen mit Imipenem/Cilastatin in der gleichen Dosierung bei 66 Fieberepisoden von 61 erwachsenen neutropenischen Patienten. 72 Stunden nach Therapiebeginn erhielten noch 25/31 Patienten aus der Meropenem-Gruppe und 24/30 Patienten aus der Behandlungsgruppe mit Imipenem/Cilastatin die usprünglich zugewiesene Initialtherapie (Hauptzielkriterium). Bei Therapieende waren in der Meropenem-Gruppe 18/31 Episoden geheilt oder gebessert gegenüber 18/30 in der Gruppe mit Imipenem/Cilastatin. Weitere 10 Infektionsepisoden, die initial mit Meropenem behandelt wurden, und sechs Infektionsepisoden aus der Vergleichsgruppe konnten erfolgreich behandelt werden, nachdem eine zusätzliche antimikrobielle Substanz verabreicht worden war (Heilung nach Therapiemodifikation). Das zufriedenstellende bakteriologische Ansprechen (Keimelimination sowie vermutete Keimelimination) mit der Initialtherapie Meropenem betrug 9/11 und 14/16 mit Imipenem/Cilastatin. Beide Antibiotika wurden gut vertragen; es wurden jedoch unter Imipenem/Cilastatin mehr Fälle von Übelkeit und/oder Erbrechen registriert (7/33 vs 2/33 unter Meropenem). Die Carbapenem-Antibiotika Meropenem und Imipenem/Cilastatin scheinen geeignet für die empirische Monotherapie bei Fieberepisoden neutropenischer Patienten zu sein. Meropenem erlaubt durch seine offensichtlich bessere Verträglichkeit im Vergleich zu Impienem/Cilastatin auch eine optimale Dosierung bei diesem Patientengut.
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Shah, P.M., Stille, W., Böhme, A. et al. Empirical monotherapy with meropenem versus imipenem/cilastatin for febrile episodes in neutropenic patients. Infection 24, 480–484 (1996). https://doi.org/10.1007/BF01713054
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DOI: https://doi.org/10.1007/BF01713054