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NCT00398099 Clinical Trial

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

Pneumonia Clinical Trial

Official title:
Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00398099
Other study ID # 0826-052
Secondary ID 2006_046
Status Completed
Phase Phase 3
First received November 9, 2006
Last updated February 16, 2017
Start date July 2005
Est. completion date January 2006

Study information
Verified date February 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To collect clinical response data with the use of ertapenem in approved indications.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0826, ertapenem sodium / Duration of Treatment: 14 Days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
Secondary Safety and Tolerability
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