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Ertapenem in community-acquired sepsis
NCT00397956Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- Dec 2005
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- ertapenem
- Conditions
- sepsis
01
Overview
Phase 3, open-label, single-arm trial of ertapenem in sepsis, sponsored by Merck & Co. Primary endpoint: Signs and symptoms of infection at Day 14. Started Sep 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Ertapenem Treatment
Single arm receiving Ertapenem
03
Who it enrols
Adults with community-acquired sepsis presenting with at least two signs (fever, tachycardia, tachypnea, leukocytosis). Excludes patients with APACHE II score > 15, resistant pathogens, or need for other antibiotics.
04
Endpoints
Primary
Signs and symptoms of infection
Secondary
Safety and Tolerability
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