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To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398099
First Posted: November 10, 2006
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
To collect clinical response data with the use of ertapenem in approved indications.

Condition Intervention Phase
Infection Pneumonia Urinary Tract Infection Drug: MK0826, ertapenem sodium / Duration of Treatment: 14 Days Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: July 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398099


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00398099     History of Changes
Other Study ID Numbers: 0826-052
2006_046
First Submitted: November 9, 2006
First Posted: November 10, 2006
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pneumonia
Urinary Tract Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases
Ertapenem
Anti-Infective Agents
Anti-Bacterial Agents