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To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00398099
First received: November 9, 2006
Last updated: February 2, 2007
Last verified: February 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Merck:

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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398099

Locations
Taiwan
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00398099     History of Changes
Other Study ID Numbers: 2006_046
Study First Received: November 9, 2006
Last Updated: February 2, 2007
Health Authority: Taiwan: National Bureau of Controlled Drugs

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

ClinicalTrials.gov processed this record on May 19, 2013