Infection, Pneumonia, Urinary Tract Infection
Conditions
Brief summary
To collect clinical response data with the use of ertapenem in approved indications.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | — |
Outcome results
None listed