Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Urinary Tract Infection

Treatments: Drug: Comparator: ceftriaxone sodium; Drug: ertapenem sodium (MK0826)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014013

MK0826-055

2009_690

0826-055

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

Enrollment: 271 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with a suspected or documented complicated urinary tract infection
• Female patients must test negative for pregnancy and agree to use adequate birth control measures
• Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy

Exclusion criteria

• Patients with complete obstruction of any portion of the urinary tract
• Patients with rapidly progressive or terminal illness
• Renal transplant patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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271 participants in 2 patient groups

ertapenem sodium (MK0826)

Experimental group

Description:

ertapenem sodium

Treatment:

Drug: ertapenem sodium (MK0826)

ceftriaxone sodium

Active Comparator group

Description:

ceftriaxone sodium

Treatment:

Drug: Comparator: ceftriaxone sodium