Dettagli per singolo studio

DEC-NET Serial number GB469

Published online	13/09/2005 16.56.00
Last updated	19/09/2005 14.15.05



Current trial status	Planned (i.e. not yet recruiting participants)
First subject enrolment Target N. of subjects	03/2006 1376
Major Disease (ICD9 class)	ACUTE FEBRILE MUCOCUTANEOUS LYMPH NODE SYNDROME (M
Experimental drug
METHYLPREDNISOLONE Treatment regimen (dosage and duration) Methylprednisolone sodium succinate - 30 milligrams per kilogram of body weight (maximum, 1.5 grams) intravenously, as a single dose
PREDNISOLONE Treatment regimen (dosage and duration) Prednisolone sodium phosphate - 2 milligrams per kilogram per day (maximum dose, 60 mg per day) in two divided doses orally for 7 days.
Gender	Both
Age (range)	month to 18 years, inclusively
Eligibility criteria
Inclusion criteria
Patients aged 1 month to 18 years, inclusively, who present with either of the following (1. OR 2.) may be included in the trial: 1. a history of fever for at least 4 days, but not more than 10 days, in addition to Ён 4 of the 5 following features, identified by history and/or at presentation: a. Oral mucosal changes ЈC any one of: i. redness, dryness, cracking, fissuring, peeling or bleeding of lips ii. diffuse redness of oral and pharyngeal mucosae, or iii. strawberry tongue (e.g., deep redness, prominent fungiform papillae) b. Extremity changes ЈC redness of palms and soles, and/or induration (swelling) of hands and feet c. Skin rash ЈC any rash that is non-vesicular and non-bullous d. Conjunctivitis ЈC bilateral and non-purulent e. Anterior cervical lymphadenopathy (any) OR 2. a history of fever for at least 5 days, but not more than 10 days, in addition to 3 of the 5 features listed above AND any one of: a. serum C-reactive protein (CRP) Ён 30 mg/L, or b. serum erythrocyte sedimentation rate (ESR) Ён 40 mm/hr, or c. plasma viscosity Ён 1.7 mPa/s Not all of these clinical features need be present at enrolment or at a single point in time. ЁАFeverЁБ is considered to be pyrexia by history (e.g., tactile assessment by parent) OR by direct measurement. Whenever measured, fever is defined as a temperature of Ён 38.0 ЁуC (100.4 ЁуF) , determined by any method (e.g., oral, rectal, tympanic or axillary). A parental impression of pyrexia by tactile assessment alone can be taken as a day of fever, regardless of any measured temperature. The first day of fever is taken as the day on which the parent or guardian reports that the child first had a fever, either by history or recorded measurement.
Exclusion criteria
None given
Trial design/methodology
Phase	3
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
The goal of the study is to answer the following: In children with acute Kawasaki disease, does the addition of systemic corticosteroids to standard therapy (IVIG, ASA) within 10 days of onset of fever affect the occurrence of coronary artery aneurysm or dilatation at 2 months after onset, when compared to placebo?
Primary outcomes
The major outcome of the study is the incidence of pre-defined abnormality of one or more coronary arteries at 8 weeks after fever onset. Coronary artery abnormality is defined in the detailed study protocol and includes both coronary artery dilatation and aneurysm. Coronary artery dilatation is defined as an intraluminal CA diameter of ≥ 3 mm but < 4 mm in a child < 5 yo and ≥ 4 mm but < 5 mm in a child ≥ 5 yo.
Secondary outcomes
The secondary goals of the study are to determine, in treatment and placebo groups, rates of: . Coronary artery abnormality at 1 year after disease onset . Days to defervescence, calculated as number of consecutive days on which child has at least one temperature > or = 38.0 АC . Fever recrudescence within 2 weeks, defined as recurrence of fever at > or = 48 hours following first IVIG infusion and defervescence (no temperature > or = 38.0 АC for > or = 24 h) . Treatment non-responsiveness, defined as fever persistent for > or = 6 days after start of IVIG . Duration of other KD symptoms . Persistence of any other KD symptoms for > or = 14 days . Number of doses of IVIG (1 or 2) . Serious Adverse Events (SAE): - Death . all cause, cardiac cause, non-cardiac cause - Morbidity within 12 months of treatment initiation (e.g., myocardial infarction, coronary artery thrombosis, other arterial thromboses, congestive heart failure) . Other Adverse Events (AE): - Abnormalities of other arterial vessels (e.g., great vessels, aorta) - Adverse effects attributable to corticosteroid, e.g. acute severe hypertension, severe glycosuria
Summary of study design, objectives, and ongoing research findings
This is a randomised, double-blinded, placebo-controlled, multi-centre phase 3 trial to compare systemic corticosteroids versus placebo on the background of standard therapy for Kawasaki disease. The primary endpoint is abnormal coronary artery diameter on echocardiography, defined by standardised criteria and normalised for body surface area, 8 to 10 weeks after randomisation. Secondary endpoints include coronary artery dilatation at 1 year, duration and persistence of fever, and adverse events.