Directly to content
  1. Publishing |
  2. Search |
  3. Browse |
  4. Recent items rss |
  5. Open Access |
  6. Jur. Issues |
  7. DeutschClear Cookie - decide language by browser settings

Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial

Kalvelage, Christina ; Zacharowski, Kai ; Bauhofer, Artur ; Gockel, Ulrich ; Adamzik, Michael ; Nierhaus, Axel ; Kujath, Peter ; Eckmann, Christian ; Pletz, Mathias W. ; Bracht, Hendrik ; Simon, Tim-Philipp ; Winkler, Michael ; Kindgen-Milles, Detlef ; Albertsmeier, Markus ; Weigand, Markus ; Ellger, Björn ; Ragaller, Maximilian ; Ullrich, Roman ; Marx, Gernot

In: Trials, 20 (2019), Nr. 156. pp. 1-10. ISSN 1745-6215

[img]
Preview
PDF, English - main document
Download (973kB) | Lizenz: Creative Commons LizenzvertragPersonalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial by Kalvelage, Christina ; Zacharowski, Kai ; Bauhofer, Artur ; Gockel, Ulrich ; Adamzik, Michael ; Nierhaus, Axel ; Kujath, Peter ; Eckmann, Christian ; Pletz, Mathias W. ; Bracht, Hendrik ; Simon, Tim-Philipp ; Winkler, Michael ; Kindgen-Milles, Detlef ; Albertsmeier, Markus ; Weigand, Markus ; Ellger, Björn ; Ragaller, Maximilian ; Ullrich, Roman ; Marx, Gernot underlies the terms of Creative Commons Attribution 4.0

Citation of documents: Please do not cite the URL that is displayed in your browser location input, instead use the DOI, URN or the persistent URL below, as we can guarantee their long-time accessibility.

Abstract

Background: Peritonitis is responsible for thousands of deaths annually in Germany alone. Even source control (SC) and antibiotic treatment often fail to prevent severe sepsis or septic shock, and this situation has hardly improved in the past two decades. Most experimental immunomodulatory therapeutics for sepsis have been aimed at blocking or dampening a specific pro-inflammatory immunological mediator. However, the patient collective is large and heterogeneous. There are therefore grounds for investigating the possibility of developing personalized therapies by classifying patients into groups according to biomarkers. This study aims to combine an assessment of the efficacy of treatment with a preparation of human immunoglobulins G, A, and M (IgGAM) with individual status of various biomarkers (immunoglobulin level, procalcitonin, interleukin 6, antigen D-related human leucocyte antigen (HLA-DR), transcription factor NF-κB1, adrenomedullin, and pathogen spectrum).

Methods/design: A total of 200 patients with sepsis or septic shock will receive standard-of-care treatment (SoC). Of these, 133 patients (selected by 1:2 randomization) will in addition receive infusions of IgGAM for 5 days. All patients will be followed for approximately 90 days and assessed by the multiple-organ failure (MOF) score, by the EQ QLQ 5D quality-of-life scale, and by measurement of vital signs, biomarkers (as above), and survival.

Discussion: This study is intended to provide further information on the efficacy and safety of treatment with IgGAM and to offer the possibility of correlating these with the biomarkers to be studied. Specifically, it will test (at a descriptive level) the hypothesis that patients receiving IgGAM who have higher inflammation status (IL-6) and poorer immune status (low HLA-DR, low immunoglobulin levels) have a better outcome than patients who do not receive IgGAM. It is expected to provide information that will help to close the knowledge gap concerning the association between the effect of IgGAM and the presence of various biomarkers, thus possibly opening the way to a personalized medicine.

Trial registration: EudraCT, 2016–001788-34; ClinicalTrials.gov, NCT03334006. Registered on 17 Nov 2017. Trial sponsor: RWTH Aachen University, represented by the Center for Translational & Clinical Research Aachen (contact Dr. S. Isfort).

Item Type: Article
Journal or Publication Title: Trials
Volume: 20
Number: 156
Publisher: BioMed Central
Place of Publication: London
Date Deposited: 13 May 2019 09:11
Date: 2019
ISSN: 1745-6215
Page Range: pp. 1-10
Faculties / Institutes: Medizinische Fakultät Heidelberg > Universitätsklinik für Anaesthesiologie
Subjects: 610 Medical sciences Medicine
Uncontrolled Keywords: Personalized medicine, Biomarkers, Pentaglobin, IgGAM, Sepsis, Peritonitis, Severe bacterial infection
About | FAQ | Contact | Imprint |
OA-LogoDINI certificate 2013Logo der Open-Archives-Initiative