To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-01-31

Brief Summary

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To collect clinical response data with the use of ertapenem in approved indications.

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Detailed Description

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Conditions

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Infection Pneumonia Urinary Tract Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0826, ertapenem sodium / Duration of Treatment: 14 Days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients, 20 years of age or older
* Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
* Patients who required therapy prior to identification of cause of infection

Exclusion Criteria

* Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
* Patient has an apache ii \> 30.
* Patient has an infection caused by pathogens resistant to ertapenem
* Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
* The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No