Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00318552
First received: April 25, 2006
Last updated: January 25, 2011
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sepsis |
Drug: Meropenem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study. |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
- 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
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2002 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female subjects aged ≥ 18, requiring intensive care treatment related to secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic therapy.
Exclusion Criteria:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318552
Locations
| Hungary | |
| Research Site | |
| Baja, Hungary | |
| Research Site | |
| Budapest, Hungary | |
| Research Site | |
| Eger, Hungary | |
| Research Site | |
| Kecskemet, Hungary | |
| Research Site | |
| Kistarcsa, Hungary | |
| Research Site | |
| Miskolc, Hungary | |
| Research Site | |
| Pecs, Hungary | |
| Research Site | |
| Siofok, Hungary | |
| Research Site | |
| Szekesfehervar, Hungary | |
| Research Site | |
| Szolnok, Hungary | |
| Research Site | |
| Szombathely, Hungary | |
| Research Site | |
| Veszprem, Hungary | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca CRR Central and Eastern Europe, Hungary Medical Director, MD | AstraZeneca |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00318552 History of Changes |
| Other Study ID Numbers: | 3591/9014, D9211C09014 |
| Study First Received: | April 25, 2006 |
| Last Updated: | January 25, 2011 |
| Health Authority: | Hungary: National Institute of Pharmacy |
Keywords provided by AstraZeneca:
|
Antibiotic Therapy sepsis treatment Meropenem |
Additional relevant MeSH terms:
|
Sepsis Toxemia Systemic Inflammatory Response Syndrome Infection Inflammation Pathologic Processes |
Shock Anti-Bacterial Agents Meropenem Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013