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

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.
 
ClinicalTrials.gov Identifier: NCT00397956
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
To collect clinical response data with the use of ertapenem in community acquired sepsis.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment

Secondary Outcome Measures :
  1. Safety and Tolerability

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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 LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00397956    
Other Study ID Numbers: 0826-053
2006_047
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents