To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)
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: Infection; Pneumonia; Urinary Tract Infection
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 approved indications.
Clinical Details
Official title: Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy
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: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patients, 20 years of age or older
- Patients did not receive any systemic antibiotic before enrollment, or patients with
failed clinical response (no improvement on symptoms or laboratory data) through
previous antibiotic treatment
- Patients who required therapy prior to identification of cause of infection
Exclusion Criteria:
- Patient has a concomitant infection that may interfere with the evaluation of the
response to ertapenem
- Patient has an apache ii > 30.
- Patient has an infection caused by pathogens resistant to ertapenem
- Patients with known allergy to ertapenem or other drugs in the same carbapenem class,
beta - lactams, lidocaine or local anesthetics of the amide type
- The patient requires antibiotics other than ertapenem (such as: glycopeptides,
macrolides or antifungal agents)
Locations and Contacts
Additional Information
Starting date: July 2005
Last updated: November 28, 2014
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