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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
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.
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.
University Hospital Aachen - Dep. of Anesthesiology
Aachen, Germany
Klinikum Augsburg - Dep. of Anesthesiology and Intensive Care Medicine
Augsburg, Germany
Charité Berlin - Dep. of Anesthesiology and Intensive Care Medicine
Berlin, Germany
Charité Berlin - Dep. of Medicine (Cardiology, Angiology, Pneumology)
Berlin, Germany
Charité Campus Mitte -Dep.of Infectiology and Pneumonology
Berlin, Germany
Mean total SOFA score
Time frame: study duration but not longer than 14 days
Mortality
Time frame: 28 and 90 days
ICU and hospital length of stay
Response to therapy
Time frame: day 7 and day 10
Clinical and microbiological cure
Time frame: End of study therapy (day 7-14) and release from ICU (max. day 21)
Frequency of adverse events (AEs, SAEs, SUSARs)
Ventilator free days
Time frame: 28 and 90 days
Days without renal replacement therapy
Time frame: 28 and 90 days
Vasopressor free days
Time frame: 28 and 90 days
SOFA-subscores
Antibiotics free days
Time frame: 28 and 90 days
Costs of antibiotic therapy
Time frame: ICU stay
Frequency of resistances to antibiotics
Time frame: ICU stay
Frequency of new infections
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Charité Campus Benjamin Franklin - Dep. of Medicine IV
Berlin, Germany
Vivantes Klinikum Neukölln - Cardiology
Berlin, Germany
Vivantes Klinikum Neukölln - Dep. of Anesthesiology, Intensive Care Medicine and Pain Therapy
Berlin, Germany
Charité Berlin - Campus Virchow-Klinikum - Dep. of Nephrology
Berlin, Germany
Ev. Krankenhaus Gilead I - Dep. of Anesthesiology and Intensive Care Medicine
Bielefeld, Germany
...and 42 more locations