G-CSF in the Treatment of Toxic Epidermal Necrolysis

Phase 4

Completed

• Conditions: Stevens - Johnson Syndrome
• Interventions: Drug: recombinant granulocyte - colony stimulating factor; Drug: NaCl 0.9%

• Registration Number: NCT02739295
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Study Start: 2016-07
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF	recombinant granulocyte - colony stimulating factor	An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.
Placebo	NaCl 0.9%	An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4.

Primary Outcome Measures

Name	Time	Method
Time for healing	From date of randomization until the date of complete healing, assessed up to 30 days.	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)	At admission and at day 5	Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
Biological data: Neutrophilic count	Every day during the 14th first days	Neutrophilic count

Secondary Outcome Measures

Name	Time	Method
Biological data: WBC count	3 months after discharge	WBC count
Biological data: WBC formula	3 months after discharge	WBC formula

Trial Locations

Locations (2)

Burn Centre of the University Hospital of Liège; 🇧🇪 Liège, Belgium

IMTR Burn Centre; 🇧🇪 Loverval, Belgium