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

Study Overview
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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.

Official Title
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A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: ertapenem sodium (MK0826)
* Drug: Comparator: ceftriaxone sodium


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ertapenem sodium (MK0826)<br>ertapenem sodium | Drug: ertapenem sodium (MK0826)<br>* 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)<br>* Other names: MK0826;|
| Active Comparator: ceftriaxone sodium<br>ceftriaxone sodium | Drug: Comparator: ceftriaxone sodium<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Response Assessment Profile | The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed | 5 to 9 days post-therapy | 
| The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment | Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences. | Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response Assessment Profile | The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed | 5 to 9 days post-therapy |