Does GM-CSF ( a drug which stimulates the production of white blood cells) restore effective neutrophil (the key white blood cell in fighting infection) function in critically ill patients?

• Conditions: Complement mediated dysfunctional neutrophil phagocytosis in critical illness.; MedDRA version: 14.1Level: PTClassification code 10061314Term: Neutrophil function disorderSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 16.1Level: LLTClassification code 10017500Term: Functional disorders of polymorphonuclear neutrophilsSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 14.1Level: PTClassification code 10061867Term: Neutrophil function test abnormalSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-005815-10-GB
• Lead Sponsor: ewcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-03
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients admitted to intensive care unit within the last 72 hours
Fulfill criteria for systemic inflammatory response syndrome (SIRS)
Have required exogenous support of one or more organ systems (invasive ventilation, inotropes or haemofiltration) during current ICU stay
Survival over next 48 hours considered to be the most likely outcome over this time by the attending clinician at the time of enrollment
Neutrophil phagocytic capacity is low (i.e. < 50% neutrophil phagocytic capacity)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

Absence/refusal of informed consent
Current prescription of a colony stimulating factor
Any history of adverse reaction/allergy to GM-CSF
Total white cell count > 30x10^9/litre at the time of screening
Haemoglobin <7.5g/dl at the time of screening
Age < 18 years
Pregnancy or lactation
Known in-born errors of neutrophil metabolism
Known haematological malignancy and/or known to have > 10% peripheral blood blast cells
Known aplastic anaemia or pancytopaenia
Platelet count <50x10^9/litre
Chemotherapy or radiotherapy within the last 24 hours
Solid organ or bone marrow transplantation
Use of maintenance immunosuppressive drugs other than maintenance corticosteroids (allowed up to prednisolone 10mg/day or equivalent)
Known human immunodeficiency virus (HIV) infection
Active connective tissue disease (eg rheumatoid disease, systemic lupus erythematosus) requiring active pharmacological treatment
ST segment elevation myocardial infarction, acute pericarditis (by ECG criteria) or pulmonary embolism (radiologically confirmed) in the previous week
Involvement in any study involving an investigational medicinal product in the previous 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified