NCT00252915

Brief Summary

There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_2 sepsis

Timeline
Completed

Started Nov 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 26, 2011

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

November 14, 2005

Last Update Submit

May 24, 2011

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9

    after therapy

Study Arms (1)

Verum

EXPERIMENTAL

GM-CSF therapy

Biological: GM-CSF (verum)

Interventions

GM-CSF (verum)BIOLOGICAL

sagramostim

Verum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe sepsis or septic shock,
  • Presence of infection,
  • SIRS criteria,
  • Acute organ dysfunction,
  • Immunoparalysis,
  • Informed consent

You may not qualify if:

  • Pregnancy,
  • Known allergies to study medication or components,
  • Moribound patient,
  • Autoimmune disease,
  • HIV-infection,
  • Acute MI or pulmonary embolism,
  • Cpr during last 72 hours,
  • Patients who participate in a different clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Meisel C, Schefold JC, Pschowski R, Baumann T, Hetzger K, Gregor J, Weber-Carstens S, Hasper D, Keh D, Zuckermann H, Reinke P, Volk HD. Granulocyte-macrophage colony-stimulating factor to reverse sepsis-associated immunosuppression: a double-blind, randomized, placebo-controlled multicenter trial. Am J Respir Crit Care Med. 2009 Oct 1;180(7):640-8. doi: 10.1164/rccm.200903-0363OC. Epub 2009 Jul 9.

    PMID: 19590022DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Hans-Dieter Volk, MD

    Charite University, Berlin, Germany

    STUDY CHAIR

  • Joerg C Schefold, MD

    Charite University Medicine

    PRINCIPAL INVESTIGATOR

  • Christian Meisel, MD

    Charite University Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 15, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2007

Study Completion

April 1, 2007

Last Updated

May 26, 2011

Record last verified: 2009-07