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

Phase 3

Completed

• Conditions: Infection; Pneumonia; Urinary Tract Infection

• Registration Number: NCT00398099
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability