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Comparison of Two Antibiotic Regimen (Meropenem Versus Meropenem+Moxifloxacin)in the Treatment of Severe Sepsis and Septic Shock

NCT00534287 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2012-06-29

No results posted yet for this study

Summary

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.

Conditions

  • Severe Sepsis
  • Septic Shock

Interventions

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.

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Bayer

    collaborator INDUSTRY

  • Kompetenznetz Sepsis

    lead NETWORK

Principal Investigators

  • Konrad Reinhart, MD · University Hospital Jena; Dep. of Anesthesiology and Intensive Care Medicine

  • Markus Löffler, MD · University Leipzig; Koordinierungszentrum für Klinische Studien Leipzig (KKSL)

  • Thomas Deufel, MD · University Hopitel Jena, Institute for Medical Chemistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-04-30
Completion
2010-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534287 on ClinicalTrials.gov