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| ID | Type | Description | Link |
|---|---|---|---|
| D9211C09014 | Other Identifier | AZ IMPACT |
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This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days from randomization to recovery from sepsis among those patients who survived the trial period | ||
| Endpoint considered in conjunction with observed mortality rates to determine whether any reduction in time to recovery from sepsis |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days from randomization to ready to discharge from the ICU | ||
| Number of days from randomization until patient is discharged from the ICU | ||
| Number of days on first line antibiotic therapy |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baja | Hungary | ||||
| Research Site |
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| Number of days from randomization until patient is discharged from hospital |
| Proportion of patients who achieve clinical cure from sepsis following first line antibiotic therapy |
| Proportion of all patients who are ready to discharge from the ICU following antibiotic therapy |
| Mortality rate due to "all causes" in the meropenem group and the standard antibiotic therapy group |
| Mortality rate due to infection in the meropenem group and the standard antibiotic therapy group |
| Health Economics-Resource utilization for main treatment and diagnostic procedures, tools and materials |
| Budapest |
| Hungary |
| Research Site | Eger | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Kistarcsa | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Siófok | Hungary |
| Research Site | Székesfehérvár | Hungary |
| Research Site | Szolnok | Hungary |
| Research Site | Szombathely | Hungary |
| Research Site | Veszprém | Hungary |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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