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To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00397956
First received: November 9, 2006
Last updated: February 2, 2007
Last verified: February 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Merck:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397956

Locations
Taiwan
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00397956     History of Changes
Other Study ID Numbers: 2006_047
Study First Received: November 9, 2006
Last Updated: February 2, 2007
Health Authority: Taiwan: National Bureau of Controlled Drugs

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

ClinicalTrials.gov processed this record on May 21, 2013