NCT01653665

Does GM-CSF Restore Neutrophil Phagocytosis in Critical Illness?

Does GM-CSF Restore Effective Neutrophil Function in Critically Ill Patients?

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite the introduction of multiple preventative measures rates of hospital acquired infection in the intensive care unit remain high. New approaches to tackling this problem are required. The neutrophil (a type of white blood cell) is the key cell fighting bacterial and fungal infection in the body. This research group has already shown that the majority of patients on intensive care have neutrophils which don't ingest germs effectively and are therefore less able to fight infection. These patients, whose white blood cells don't work properly, are much more likely to develop a second infection whilst in hospital (hospital acquired infection). Previous work done by this group has shown that by adding a drug called granulocyte macrophagecolony stimulating factor (GM-CSF) to a sample of blood from these patients in the lab, it is possible to restore the ability of the white blood cells to ingest bacteria and fight infection. This study will test whether it is possible to restore the capacity of patients' white blood cells to eat germs by giving them GM-CSF as an injection while they are on intensive care. The study will involve identifying adult patients on intensive care whose white blood cells don't work properly in this way. Patients taking part in the study will receive an injection, under the skin, of either the drug, GM-CSF, or a solution which will have no effect (placebo). The investigators will compare whether those patients who have received the GM-CSF injection have an improvement in the function of the white blood cells compared to those who don't. As well as looking at the function of the white blood cells the investigators will also study whether there is a difference in the rates of infection picked up in hospital between the two groups. This study is funded by the Medical Research Council.

Conditions

• Critical Illness
• Sepsis
• Immuno-suppression

Interventions

Type	Name	Description
DRUG	Leukine	Daily subcutaneous injection of either 3 or 6 micrograms per kilo per day, for either 4 or 7 days.
DRUG	Normal Saline	Patients in the randomised controlled trial may receive this placebo as a single daily subcutaneous injection. The volume will match that of the active drug.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2012-07-31
• Last updated: 2018-02-13

Locations

4 sites across 1 country: United Kingdom