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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Sepsis

Treatments: Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00397956

0826-053

2006_047

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)