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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 9, 2006
Last updated: October 29, 2015
Last verified: October 2015
To collect clinical response data with the use of ertapenem in community acquired sepsis.

Condition Intervention Phase
Sepsis Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Secondary Outcome Measures:
  • Safety and Tolerability

Estimated Enrollment: 30
Study Start Date: September 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00397956

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00397956     History of Changes
Other Study ID Numbers: 0826-053
Study First Received: November 9, 2006
Last Updated: October 29, 2015

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents processed this record on September 21, 2017