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| Sponsor: | Kompetenznetz Sepsis |
|---|---|
| Collaborators: |
AstraZeneca Bayer |
| Information provided by: | Kompetenznetz Sepsis |
| ClinicalTrials.gov Identifier: | NCT00534287 |
Purpose
Severe sepsis and septic shock are diseases of infectious origin with a high risk of death. Antibiotic therapy is mandatory but it is unknown whether one antibiotic alone is sufficient for initial therapy. The purpose of this study is to compare a therapy with meropenem alone or the combination of meropenem plus moxifloxacin in the treatment of severe sepsis/ septic shock. Patients randomly receive one of the two treatments for at least 7 days but not longer than 14 days.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Sepsis Septic Shock |
Drug: meropenem Drug: meropenem, moxifloxacin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prospective, Randomized, Open, Multicentre Study About the Effect of an Empirical Antibiotic Monotherapy With Meropenem (Meronem®) Versus a Combination Therapy With Moxifloxacin (Avalox®) on Organ Dysfunction in Patients With Severe Sepsis and Septic Shock |
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
MeroMono: Active Comparator
Monotherapy with meropenem
|
Drug: meropenem
Empirical antibiotic therapy with 3 x 1 g intravenous meropenem. Dosage is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
|
|
MeroMoxi: Active Comparator
Combination therapy with meropenem + moxifloxacin
|
Drug: meropenem, moxifloxacin
Empirical antibiotic therapy with 3 x 1 g intravenous meropenem plus 1 x 400 mg intravenous moxifloxacin. Dosage of meropenem is adjusted in case of renal dysfunction. Recommended duration of therapy is 7 days but can be extended up to 14 days.
|
Early intravenous empiric broad-spectrum antimicrobial therapy is an essential part of sepsis therapy. Inadequacy of empirical antibiotic therapy is associated with an increased mortality rate. Carbapenems are designed for empirical antimicrobial monotherapy. Combination therapy has been suggested but efficiency remains to be proven. In this study, antimicrobial monotherapy with meropenem is compared with a combination therapy of meropenem and moxifloxacin. It is hypothesized that the superior antibiotic therapy is associated with a lower overall organ dysfunction in sepsis. Study therapy lasts for at least 7 days unless microbiological results suggest otherwise. Study therapy may be extended to 14 days. Follow up examinations occur at 28 and 90 days. This investigator initiated study is supported by the German government (bmbf) and unrestricted industrial grants.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Frank M. Brunkhorst, M.D. | +49-3641-9323383 | Frank.Brunkhorst@med.uni-jena.de |
Show 53 Study Locations| Study Chair: | Konrad Reinhart, MD | University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine |
| Study Director: | Markus Löffler, MD | University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL) |
| Study Director: | Thomas Deufel, MD | University Hopitel Jena, Institute for Medical Chemistry |
More Information
| Study ID Numbers: | EudraCT 2006-006984-21, bmbf grant: 01 KI 01 06 |
| Study First Received: | September 21, 2007 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00534287 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
sepsis antibiotics carbapenems fluoroquinolones Severe sepsis and septic shock |
|
Systemic Inflammatory Response Syndrome Anti-Infective Agents Infection Pharmacologic Actions Inflammation Anti-Bacterial Agents Sepsis |
Pathologic Processes Shock Moxifloxacin Meropenem Therapeutic Uses Shock, Septic |