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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ertapenem sodium (MK0826)

ertapenem sodium

Group Type EXPERIMENTAL

ertapenem sodium (MK0826)

Intervention Type DRUG

a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed)

ceftriaxone sodium

Group Type ACTIVE_COMPARATOR

Comparator: ceftriaxone sodium

Intervention Type DRUG

a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)

Interventions

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ertapenem sodium (MK0826)

a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed)

Intervention Type DRUG

Comparator: ceftriaxone sodium

a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)

Intervention Type DRUG

Other Intervention Names

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MK0826

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No