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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397956
First Posted: November 10, 2006
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397956


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00397956     History of Changes
Other Study ID Numbers: 0826-053
2006_047
First Submitted: November 9, 2006
First Posted: November 10, 2006
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ertapenem
Anti-Infective Agents
Anti-Bacterial Agents