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Infection

, Volume 23, Issue 4, pp 222–226 | Cite as

A multicentre, randomized comparative study of 500 mg versus 1,000 mg ceftazidime t.d.s. for treatment of gram-negative infections

  • H. Mattie
  • H. I. Schievink
  • M. W. Kunst
  • P. L. Jonker
  • P. de Jonge
Originalia
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Summary

A multicentre, randomized study was performed to compare the clinical and bacteriological efficacy of 500 mg ceftazidime i.v. t.d.s. with 1,000 mg ceftazidime i.v. t.d.s. for treatment of hospitalised, non-compromised patients with gram-negative infections. The study was conducted in ten hospitals in The Netherlands. Hospitalised patients with a suspected gram-negative lower respiratory tract infection, complicated urinary tract infection or septicaemia were included. Excluded were patients with neutropenia, limited life expectancy, or severe renal insufficiency as well as those on antibiotics in the 48 h prior to entry. Ceftazidime was administered via an intravenous infusion every 8 h. For patients with moderately impaired renal function the frequency was reduced to 12 h. Treatment was continued for as long as clinically indicated. Clinical response (cure, improvement or failure) and bacteriological response (elimination, persistence or non-evaluable) were assessed primarily by the investigator. Final assessments were made by a panel of experts without prior knowledge. In total 127 patients were randomized, 64 patients to the 500 mg group and 63 to the 1,000 mg group; 47 patients were excluded from evaluation, usually due to an incorrect diagnosis prior to randomization. Ultimately 37 patients of the 500 mg group and 43 patients of the 1,000 mg group were available for evaluation. Between these two groups of evaluable patients there were no significant differences in baseline characteristics, types of infection, isolated bacterial pathogens or treatment characteristics. There was no significant difference in either clinical or bacteriological efficacy. Therefore 500 mg ceftazidime i.v. t.d.s. can be considered optimal therapy for gram-negative lower respiratory tract infections, complicated urinary tract infections and septicaemia in hospitalised, non-compromised patients.

Keywords

Neutropenia Ceftazidime Incorrect Diagnosis Complicated Urinary Tract Infection Limited Life Expectancy 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Multizentrische, randomisierte Vergleichsstudie zur Behandlung gramnegativer Infektionen mit 500 mg oder 1.000 mg Ceftazidim t.i.d.

Zusammenfassung

Bei stationären Patienten mit gramnegativen Infektionen ohne Abwehrschwäche wurde eine randomisierte Multizenterstudie durchgeführt, um die klinische und bakteriologische Effizienz von Ceftazidim in einer Dosierung von 500 mg und 1.000 mg dreimal täglich zu vergleichen. An der Studie nahmen 10 Krankenhäuser in den Niederlanden teil. Eingeschlossen wurden Patienten mit Verdacht auf eine gramnegative Infektion der unteren Atemwege, mit komplizierter Harnwegsinfektion oder mit Septikämie. Ausgeschlossen waren Patienten mit Neutropenie, begrenzter Lebenserwartung oder schwerer Niereninsuffizienz sowie Patienten, denen 48 h vor Aufnahme Antibiotika verabreicht wurden. Ceftazidim wurde als intravenöse Infusion alle 8 h appliziert. Bei Patienten mit mäßig eingeschränkter Nierenfunktion wurde alle 12 Stunden dosiert. Die Behandlung wurde fortgesetzt, solange es klinisch erforderlich war. Das klinische Ansprechen (Heilung, Besserung oder Versagen) und die bakteriologischen Ergebnisse (Elimination, Persistenz, nicht auswertbar) wurden durch den Prüfer primär beurteilt und abschließend durch ein Expertengremium ohne Vorinformation bewertet. Insgesamt wurden 127 Patienten randomisiert, 64 Patienten in die Gruppe mit 500 mg Dosis, 63 in die Gruppe 1.000 mg. 47 Patienten wurden von der Auswertung ausgeschlossen, meist aufgrund fehlerhafter Diagnose vor Randomisierung. Schließlich waren 37 Patienten der 500 mg Gruppe und 43 Patienten der 1.000 mg Gruppe auswertbar. Zwischen diesen beiden Gruppen gab es keine signifikanten Unterschiede hinsichtlich der Basisdaten, der Art der Infektionen, der Erregerisolate oder der Behandlungsform. Hinsichtlich klinischer oder bakteriologischer Effizienz fanden sich keine signifikanten Unterschiede. Ceftazidim kann daher in einer Dosierung von 500 mg dreimal täglich i.v. als optimale Therapie bei gramnegativen Infektionen der unteren Atemwege, bei komplizierten Harnwegsinfektionen und bei Septikämie bei stationären Patienten ohne Abwehrschwäche angesehen werden.

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Copyright information

© MMV Medizin Verlag GmbH München 1995

Authors and Affiliations

  • H. Mattie
    • 1
  • H. I. Schievink
    • 1
  • M. W. Kunst
    • 2
  • P. L. Jonker
    • 3
  • P. de Jonge
    • 3
  1. 1.Dept. of Infectious DiseasesUniversity Hospital LeidenLeiden
  2. 2.Red Cross HospitalBeverwijk
  3. 3.Medical Dept.Glaxo BVZeist

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