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MAXSEP

Motivation:

Early appropriate antimicrobial therapy leads to lower mortality rates associated with severe sepsis. The role of empirical combination therapy comprising at least 2 antibiotics of different mechanisms remains controversial. We investigated the effect of moxifloxacin and meropenem with the effect of meropenem alone on sepsis-related organ dysfunction.

Baseline Data and Endpoints for MAXSEP

LHA ID: 7WGJ3QNXHQ-5

Investigation: MAXSEP

Projects: SepNet - German Competence Network Sepsis

Study position:

Study type: Not specified

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Creators and Submitter

Creator

Marita Ziepert

Submitter

René Hänsel

Activity

Views: 2249

Created: 20th May 2019 at 14:25

Last updated: 20th May 2019 at 14:25

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Resources (2)
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SepNet - German Competence Network Sepsis

As an interdisciplinary network of scientists, the SepNet study group deals with the topics of severe sepsis and septic shock. The aim of the network is to create the prerequisites for better clinical and experimental research into sepsis and thus to develop efficient treatment approaches.

Programme: LIFE Management Cluster

Public web page: https://www.sepsis-stiftung.eu/sepnet/

Start date: 1st Jan 2003

Organisms: Homo sapiens

Human Diseases: disease by infectious agent

MAXSEP

SepNet - German Competence Network Sepsis

All creators

Marita Ziepert

No description specified

Submitter: René Hänsel

Studies: MAXSEP

Resources: MAXSEP Trial Data, MAXSEP Trial Metadata

Snapshots: No snapshots

Created: 20th May 2019 at 14:24, Last updated: 20th May 2019 at 14:24

MAXSEP Trial Metadata

SepNet - German Competence Network Sepsis

All creators

Marita Ziepert

No description specified

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: MAXSEP

Study: MAXSEP

Human Diseases: disease by infectious agent

Data files: MAXSEP Metadata, MAXSEP Metadata-ODM

Snapshots: No snapshots

Created: 20th May 2019 at 14:26, Last updated: 29th Oct 2019 at 10:53

MAXSEP Trial Data

SepNet - German Competence Network Sepsis

All creators

Marita Ziepert

No description specified

Submitter: René Hänsel

Resource type: Experimental Assay Type

Technology type: Technology Type

Investigation: MAXSEP

Study: MAXSEP

Human Diseases: disease by infectious agent

Data files: MAXSEP, MAXSEP-ODM, MAXSEP-SPSS

Snapshots: No snapshots

Created: 20th May 2019 at 14:27, Last updated: 29th Oct 2019 at 10:53

Effect of empirical treatment with moxifloxacin and meropenem vs meropenem on sepsis-related organ dysfunction in patients with severe sepsis: a randomized trial.

SepNet - German Competence Network Sepsis

(Show All)

All authors

Markus Löffler

Christoph Engel

Konrad Reinhart

Abstract (Expand)

CONTEXT: Early appropriate antimicrobial therapy leads to lower mortality rates associated with severe sepsis. The role of empirical combination therapy comprising at least 2 antibiotics of different … mechanisms remains controversial. OBJECTIVE: To compare the effect of moxifloxacin and meropenem with the effect of meropenem alone on sepsis-related organ dysfunction. DESIGN, SETTING, AND PATIENTS: A randomized, open-label, parallel-group trial of 600 patients who fulfilled criteria for severe sepsis or septic shock (n = 298 for monotherapy and n = 302 for combination therapy). The trial was performed at 44 intensive care units in Germany from October 16, 2007, to March 23, 2010. The number of evaluable patients was 273 in the monotherapy group and 278 in the combination therapy group. INTERVENTIONS: Intravenous meropenem (1 g every 8 hours) and moxifloxacin (400 mg every 24 hours) or meropenem alone. The intervention was recommended for 7 days and up to a maximum of 14 days after randomization or until discharge from the intensive care unit or death, whichever occurred first. MAIN OUTCOME MEASURE: Degree of organ failure (mean of daily total Sequential Organ Failure Assessment [SOFA] scores over 14 days; score range: 0-24 points with higher scores indicating worse organ failure); secondary outcome: 28-day and 90-day all-cause mortality. Survivors were followed up for 90 days. RESULTS: Among 551 evaluable patients, there was no statistically significant difference in mean SOFA score between the meropenem and moxifloxacin group (8.3 points; 95% CI, 7.8-8.8 points) and the meropenem alone group (7.9 points; 95% CI, 7.5-8.4 points) (P = .36). The rates for 28-day and 90-day mortality also were not statistically significantly different. By day 28, there were 66 deaths (23.9%; 95% CI, 19.0%-29.4%) in the combination therapy group compared with 59 deaths (21.9%; 95% CI, 17.1%-27.4%) in the monotherapy group (P = .58). By day 90, there were 96 deaths (35.3%; 95% CI, 29.6%-41.3%) in the combination therapy group compared with 84 deaths (32.1%; 95% CI, 26.5%-38.1%) in the monotherapy group (P = .43). CONCLUSION: Among adult patients with severe sepsis, treatment with combined meropenem and moxifloxacin compared with meropenem alone did not result in less organ failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00534287.

Authors: F. M. Brunkhorst, M. Oppert, G. Marx, F. Bloos, K. Ludewig, C. Putensen, A. Nierhaus, U. Jaschinski, A. Meier-Hellmann, A. Weyland, M. Grundling, O. Moerer, R. Riessen, A. Seibel, M. Ragaller, M. W. Buchler, S. John, F. Bach, C. Spies, L. Reill, H. Fritz, M. Kiehntopf, E. Kuhnt, H. Bogatsch, C. Engel, M. Loeffler, M. H. Kollef, K. Reinhart, T. Welte