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Ensayo clínico aleatorizado y controlado con producto de comparación activo en fase III para estudiar la seguridad y la eficacia de MK 0826/ertapenem y meropenem en pacientes con infecciones urinarias...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-003923-21

Ensayo clínico aleatorizado y controlado con producto de comparación activo en fase III para estudiar la seguridad y la eficacia de MK 0826/ertapenem y meropenem en pacientes con infecciones urinarias complicadas. A Phase III, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0826/Ertapenem and Meropenem in Patients with Complicated Urinary Tract Infections

Femme et Homme

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Extrait

1) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious (requiring hospitalization and treatment with parenteral therapy) complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at the 5 to 9 days posttherapy (EFU/TOC) follow-up visit. 2) To compare the efficacy of ertapenem with respect to the clinical response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at completion of parenteral therapy (DCIV). 3) To compare the efficacy of ertapenem with respect to the overall microbiological response assessment profile in the treatment of patients with serious complicated UTIs, including acute pyelonephritis, with that of the meropenem control group at DCIV. 4) To evaluate the safety profile of ertapenem at DCIV.

Critère d'inclusion

  • Complicated Urinary Tract Infection,Infección complicada del tracto urinario

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