Trial · NCT04651439
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arrest of the SJS/NET progression at day 5 | On day 5 (after 5 injections of ZARZIO or PLACEBO - D0: initiation of treatment) | Comparison between the 2 arms of the proportion of patients with arrest of progression of skin detachment defined by a peeled surface and/or bullous and/or associated at a NIKOLSKY sign determined according to the stable burn table - Evaluation done by the Outcomes Assessor and the adjudication committee. |
| Secondary | Arrest of the SJS/NET progression | At day 3, day 7 and day 15 | Comparison between the 2 arms of the time until the arrest of the SJS/NET progression defined by a peeled surface and/or bullous and/or associated at a NIKOLSKY sign determined according to the stable burn table - Evaluation done by the Outcomes Assessor and the adjudication committee. |
| Secondary | Complete re-epidermization | At day 3, day 5, day 7, day 15 and day 45 | Comparison between the 2 arms of the time until the complete re-epidermization defined by the disappearance of skin rashes and return to normal skin. Evaluation done by the Outcomes Assessor and the adjudication committee. |
| Secondary | Overall survival | Until 30 days | Comparison between the 2 arms of the overall survival |
| Secondary | Overall survival | Until 1 year | Comparison between the 2 arms of the overall survival |
| Secondary | Duration of hospitalization | 15 days (maximal of SJS/NET episode's hospitalization) | Comparison between the 2 arms of the number days of hospitalization corresponding to the duration of SJS/NET episode's hospitalization. |
| Secondary | Premature discontinuation of experimental treatment | Between day 0 and day 5 | Number of clinical and biological adverse event leading to stop the filgrastim treatment (per patient, nature and grade of the AE (adverse event ) - repository CTCAE version 5.0) |
| Secondary | Adverse events | Until 1 year | Comparison between the 2 arms of the number of clinical and biological adverse event (by organ systems - repository CTCAE version 5.0).. |
| Secondary | Use of systemic corticosteroid therapy | Between day 0 and day 15 | Study of the nature, cumulative doses and indications objectifying a corticosteroid prescription. A comparison between the 2 arms will be done. |
| Secondary | Evaluation of sequels | At day 45, day 60, day 90, day 180 and 1 year | Determination of the proportion of patients with at least one sequel among the following specialty : ophthalmology, stomatology/ORL(otorhinolaryngology), gastroenterology, gynecology, urology and psychiatry, researched during specialized consultations during the remote monitoring phase. A comparison between the 2 arms will be done. |
| Secondary | Quality of life evolution | At day 60, day 180 and 1 year | Quality of life evolution assessed with Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CDLQI). DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. CDLQI is used in the same way. It is documented in 5 minutes. Each question is illustrated by a cartoon based on the theme of the question, making it more fun for younger children. The scoring for each question is "Very much"\[Score = 3\], "Quite a lot"\[2\], "Only a little"\[1\], "Not at all"\[0\], "Blank"\[0\], and Q7 - "prevented school"\[3\]. The 10 individual question scores are summed to provide a total CDLQI score. The maximum possible score is 30, indicating maximum impact on QoL. A comparison between the 2 arms will be done. |
| Secondary | Risk of developing Post Traumatic Stress Disorder (PTSD) | At day 0, day 7 and day 15 | Determination of the proportion of patients with high risk of developing PTSD measured with Impact of Event Scale Revised (IES-R) or Children's Revised Impact of Event Scale (CRIES). IES-R is a 22-item self-administered questionnaire that measures symptoms of intrusion, avoidance and over-arousal experienced during the past 7 days. Patients rate each item on a 0-5 point Likert scale. The total score, between 0 and 88, is obtained by adding all the ratings for each item: low risk (score less than 12), moderate (score between 12 and 34 inclusive) or at high risk (score strictly greater than 34) of developing PTSD. CRIES-13 is a revised scale to measure the impact of events on children from 8 years old. Items are rated on a 4-point scale, with scores of 0, 1, 3 and 5 points. The maximum score is 65. The score is obtained by adding the responses to each item. A score of 30 or more would be effective in screening for PTSD. A comparison between the 2 arms will be done. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04651439/registered