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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Anti-Infective Agents; Ertapenem

Criteria

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)

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)