Sepsis
Conditions
Brief summary
To collect clinical response data with the use of ertapenem in community acquired sepsis.
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients, 18 years of age or older * Patients present with at least two of the following signs and symptom: * fever (temperature\> 38c or \< 36c) * heart rate \> 90 beats/min) * respiratory rate\> 20 breaths/min) * high white blood cell count \> 12,000/ul or \>10% bands)
Exclusion criteria
* Patient has a history of allergy or hypersensitivity (anaphylaxis) or serious adverse reaction to ertapenem or any carbapenem * Patient has a poor chance of survival for more than 14 days. * Patient has an apache ii score \> 15 (see attachment 3. * Patient has an infection caused by pathogens resistant to ertapenem * 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