Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252915

Enrollment

Registered

2005-11-15

Start date

2005-11-30

Completion date

2007-04-30

Last updated

2011-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Detailed description

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 patinets with severe sepsis and septic shock.

Interventions

BIOLOGICALGM-CSF (verum)

sagramostim

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Severe sepsis or septic shock, * Presence of infection, * 2 SIRS criteria, * Acute organ dysfunction, * Immunoparalysis, * Informed consent

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9	after therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026