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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Infection; Urinary Tract Infection; Pneumonia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00398099

2006_046

0826-052

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)