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

Phase 1

• Conditions: Complicated urinary tract infection Infección complicada del tracto urinario; MedDRA version: 9.1 Level: LLT Classification code 10046571 Term: Urinary tract infection

• Registration Number: EUCTR2008-003923-21-ES
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-04
• Study Completion: 2009-06-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 680

Inclusion Criteria

Patient has a clinically suspected and /or bacteriologically documented complicated UTI or acute pyelonephritis judged by the investigator to be serious. Patient has one positive urine culture within 48 hours of enrollment. Patient has one or more signs or symptoms of either upper or lower UTI. Patient is male with or without a bladder catheter or urologic abnormalities; OR patient is a female with a history or clinical evidence of one or more urologic abnormalities.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has received any amount of effective concomitant antibiotic therapy after obtaining the urine culture for admission to this study (admission urine culture) and prior to the administration of the first dose of study antibiotics. Patient's infection has been treated with greater than 24 hours of systemic antibiotic therapy known to be effective against the presumed or documented pathogens within the 72 hour period immediately prior to consideration for entry into the study. Patient has complete obstruction of any portion of the urinary tract. Patient has a history of seizures other than an uncomplicated febrile seizure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified