To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis
Intervention: MK0826, ertapenem sodium / Duration of Treatment: 14 Days (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
To collect clinical response data with the use of ertapenem in community acquired sepsis.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Secondary outcome: Safety and Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Additional Information
Starting date: September 2004
Last updated: November 28, 2014
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