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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sepsis

Intervention: MK0826, ertapenem sodium / Duration of Treatment: 14 Days (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.


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

Clinical Details

Official title: An Open-Label, Single-Arm, Non-Comparative Study to Evaluate the Efficacy, Tolerability & Convenience of Invanz(TM) (Ertapenem Sodium) In the Treatment of Community-Acquired Sepsis in Adults

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment

Secondary outcome: Safety and Tolerability


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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)

Locations and Contacts

Additional Information

Starting date: September 2004
Last updated: November 28, 2014

Page last updated: August 23, 2015

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