Comparison Between Corticosteroid and Topical Steroids in the DRESS

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 12, 2013

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Eligibility criteria

• Inclusion Criteria:
• • patient age ≥ 18 years
• • signing informed consent form
• • DRESS diagnosis with at least 4 criteria a, b, c, d
• • 1. Skin rash occurring at least 10 days and not more than two months after continuous drug intake (or within less than 10 days in case of rechallenge)
• • 2. Fever ≥ 38 ° at the time of examination or fever ≥ 38.5 ° peak in the last 72 hours (amendment 2 : ANSM + CPP : 08/04/14)
• 3. at least one visceral compatible :
• • lymphadenopathy on at least two different sites measuring at least 1 cm in diameter
• • transaminases \> 2 upper limit of normal (ULN) or alkaline phosphatise \> 3 ULN
• • lung involvement defined by hypoxemia (capillary oximetry ≤ 95%) and/or interstitial lung disease on chest radiography or scanner, in absence of other lung disease
• • myocarditis, pericarditis (ECG clinical suspicion and confirmed by echocardiography)
• * renal impairment defined as creatinine increase above the normal laboratory value associated with leucocyturia \> 1000 / mm3 or proteinuria, a Na / K ratio \>1 and Urine Cyto-bacteriology (EBCU) sterile in the absence of preexisting renal disease d) At least one of the following haematological abnormalities:
• • eosinophilia ≥ 0.7 g/l or \> 10 % absolute
• • lymphocytosis ≥ 5\*10\^9 /l
• • presence of atypical blood lymphocytes
• * Patient with moderate DRESS : defined by at least one reached as follows :
• • pulmonary: interstitial pneumonia with oxygen partial pressure in arterial blood (PaO2) 60-75 mmHg without dyspnoea at rest
• • Hepatic: transaminases ≥ 4 ULN and \< 15 ULN and/or PAL ≥5 ULN and V factor 50% (amendment 2 : ANSM + CPP : 08/04/14)
• * renal :
• • acute renal failure and organic sharp increase in the 48 hours preceding the inclusion of more of 26.4 micromol/l creatinine
• • and / or increase of 1.5 times the normal creatinine value
• • and / or decrease of oliguria of less than 0.5 ml/kg/h followed by a 6 hours
• • cord: pancytopenia (7≤Hb≤10 gr/dl and/or 50\<p\<100 G/L, 0.5\<PNN≤1.5G/l)
• • AND absence of cardiac, neurological or gastrointestinal (gut, pancreas) threatening
• • Drug withdrawal
• • Patient with health insurance (or entitled beneficiary)
• • Patient accepting the constraints of the test
• Exclusion Criteria:
• • uncontrolled sepsis
• • unability to discontinue the medication(s) due
• • known hypersensitivity to systemic or topical corticosteroids
• • hepatitis B or C known, (active HIV status known suppressed by amendment 5 : ANSM16/04/2015 and CPP 07/04/2015)
• * (Patient already treated by corticosteroid :
• • More than 48 hours
• * Less than 48 hours to following conditions :
• • Patients receiving more than 1 mg/kg/day of prednisone per os
• • Patients receiving methylprednisolone pulse up to 1mg/kg prednisone equivalent
• • (Patients receiving more than 30 grams per day level 3 topical steroid or more than 10 grams per day level 4 topical steroid --\> suppressed by amendment 3 : ANSM 28/05/14 CPP : 10/06/14)
• • (Patient undergoing immunosuppressive therapy for another disease suppressed by amendment 5 : ANSM16/04/2015 and CPP 07/04/2015)
• • Participation in another drug biomedical research
• • Primitive bacterial infections, fungal or parasitic
• • Severe rosacea cont-indicating the use of corticosteroid
• • Presence of at least one ulcerated lesion (more than 10cm2)
• • Severe dermatitis perioral cont-indicating the use of corticosteroid
• • Severe acne contra-indicating the use of a corticosteroid
• • Pregnant or nursing women