To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)

Phase 3

Completed

• Conditions: Sepsis

• Registration Number: NCT00397956
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

To collect clinical response data with the use of ertapenem in community acquired sepsis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female patients, 18 years of age or older
• Patients present with at least two of the following signs and symptom:
• fever (temperature> 38c or < 36c)
• heart rate > 90 beats/min)
• respiratory rate> 20 breaths/min)
• high white blood cell count > 12,000/ul or >10% bands)

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Exclusion Criteria

• Patient has a history of allergy or hypersensitivity (anaphylaxis) or serious adverse reaction to ertapenem or any carbapenem
• Patient has a poor chance of survival for more than 14 days.
• Patient has an apache ii score > 15 (see attachment 3.
• Patient has an infection caused by pathogens resistant to ertapenem
• 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