Infection

, Volume 20, Supplement 3, pp S181–S188

Design of clinical trials in patients with urinary tract infections

  • S. R. Norrby
Session IV

Summary

This overview deals with the optimization of the design of clinical trials in patients with urinary tract infections (UTIs). Despite the fact that UTI is one of the most common types of infection and that the main end-point (elimination or persistence of bacteriuria) is objective and easy to register, the quality of studies performed and published has generally been less than optimal. Problems that should always be addressed in the study protocol are definitions of terms used, for example bacteriuria, level of the infection (cystitis or pyelonephritis), and uncomplicated and complicated infections; dimension of the patient's sample to allow adequate testing of a null hypothesis; procedures before, during and after treatment; methods for analysis of the results.

Studiendesign bei Patienten mit Harnwegsinfektionen

Zusammenfassung

In diesem Überblick wird die Optimierung klinischer Studien bei Harnwegsinfektionen (HWI) dargestellt. Obwohl HWI zu den häufigsten Infektionskrankheiten gehören und der Endpunkt (Eliminierung oder Persistenz der Bakteriurie) objektiv und leicht festzustellen ist, zeigt sich, daß die Qualität der durchgeführten und publizierten Studien im allgemeinen nicht optimal ist. Es ist wichtig, daß in allen Studienprotokollen folgende Gesichtspunkte berücksichtigt werden: Definition der verwendeten Begriffe, z. B. Bakteriurie, Ebene der Infektion (Zystitis oder Pyelonephritis) sowie unkomplizierte und komplizierte Infektion; der Umfang der Patientenstichprobe, um die Nullhypothese ausreichend zu testen; Maßnahmen vor, während und nach der Therapie; Methoden zur Analyse der Ergebnisse.

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Copyright information

© MMV Medizin Verlag GmbH München 1992

Authors and Affiliations

  • S. R. Norrby
    • 1
  1. 1.Dept. of Infectious DiseasesLund University HospitalLundSweden

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