Status:
COMPLETED
To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To collect clinical response data with the use of ertapenem in community acquired sepsis.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00397956
Start Date
September 1 2004
End Date
December 1 2005
Last Update
October 30 2015
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