Back to resultsTo Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
Primary Purpose
Sepsis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0826, ertapenem sodium / Duration of Treatment: 14 Days
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility 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)
Sites / Locations
Outcomes
Primary Outcome Measures
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Secondary Outcome Measures
Safety and Tolerability
Full Information
NCT ID
NCT00397956
First Posted
November 9, 2006
Last Updated
October 29, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00397956
Brief Title
To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
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 Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
To collect clinical response data with the use of ertapenem in community acquired sepsis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0826, ertapenem sodium / Duration of Treatment: 14 Days
Primary Outcome Measure Information:
Title
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Secondary Outcome Measure Information:
Title
Safety and Tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
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