G-CSF in the Treatment of Toxic Epidermal Necrolysis (NeupoNET)
Primary Purpose
Stevens - Johnson Syndrome
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
recombinant granulocyte - colony stimulating factor
NaCl 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Stevens - Johnson Syndrome
Eligibility Criteria
Inclusion Criteria:
- Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission
Exclusion Criteria:
- Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission
- Hypercoagulable state
- Cardiac or peripheral arterial disease
- Active malignancy
- Myelodysplastic syndrome or hematological malignancy
- Fructose intolerance
- Pregnancy
- Patient refusal
Sites / Locations
- Burn Centre of the University Hospital of Liège
- IMTR Burn Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
G-CSF
Placebo
Arm Description
An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.
An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.
Outcomes
Primary Outcome Measures
Time for healing
Time for complete cutaneous healing, considered as healing of 90% of the body surface area
Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Biological data: Neutrophilic count
Neutrophilic count
Secondary Outcome Measures
Biological data: WBC count
WBC count
Biological data: WBC formula
WBC formula
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02739295
Brief Title
G-CSF in the Treatment of Toxic Epidermal Necrolysis
Acronym
NeupoNET
Official Title
Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial.
Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stevens - Johnson Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G-CSF
Arm Type
Experimental
Arm Description
An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.
Intervention Type
Drug
Intervention Name(s)
recombinant granulocyte - colony stimulating factor
Other Intervention Name(s)
Neupogen (Amgen)
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Primary Outcome Measure Information:
Title
Time for healing
Description
Time for complete cutaneous healing, considered as healing of 90% of the body surface area
Time Frame
From date of randomization until the date of complete healing, assessed up to 30 days.
Title
Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Description
Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Time Frame
At admission and at day 5
Title
Biological data: Neutrophilic count
Description
Neutrophilic count
Time Frame
Every day during the 14th first days
Secondary Outcome Measure Information:
Title
Biological data: WBC count
Description
WBC count
Time Frame
3 months after discharge
Title
Biological data: WBC formula
Description
WBC formula
Time Frame
3 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission
Exclusion Criteria:
Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission
Hypercoagulable state
Cardiac or peripheral arterial disease
Active malignancy
Myelodysplastic syndrome or hematological malignancy
Fructose intolerance
Pregnancy
Patient refusal
Facility Information:
Facility Name
Burn Centre of the University Hospital of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
IMTR Burn Centre
City
Loverval
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
G-CSF in the Treatment of Toxic Epidermal Necrolysis
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