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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.


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


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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