Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network

NCT00132080 | Completed Phase 3 DMC

• 2 other identifiers: 241U01HL068270
• Study Type: interventional
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse events.

Conditions

Cardiovascular Diseases; Heart Diseases; Infection; Coronary Aneurysm

Outcome Measures

Primary Outcomes (1)

• Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes

  Measured 5 weeks post-randomization

Secondary Outcomes (1)

• Occurrence of CA aneurysms; individual z scores of the LMCA, proximal RCA, and proximal LAD CA at 1 and 5 weeks; changes in absolute coronary dimensions for all CA segments from baseline to 1 and 5 weeks after randomization

  Measured 5 weeks post-randomization

Study Arms (1)

1

PLACEBO COMPARATOR

Patients with acute Kawasaki disease

Drug: Steroids

Interventions

Steroids DRUG

This study evaluates the efficacy and safety of pulse steroid therapy, when added to conventional treatment with IVIG plus aspirin, in treatment of children with acute Kawasaki disease.

Also known as: pulse steroid therapy.

1

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

* Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features: 1. Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips 2. Polymorphous exanthema 3. Bilateral, painless bulbar conjunctival injection without exudates 4. Changes in lips and oral cavity: Erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae 5. Cervical lymphadenopathy ( 1.5 cm in diameter), usually unilateral; OR * Patients with at least four days of fever and coronary artery disease, defined as either: 1\. Having a z-score in either the proximal right coronary artery or the proximal left anterior descending coronary artery of \> 2.5 detected by 2-dimensional echocardiography, as well as: * For patients under six months of age, at least two principal criteria * For patients at least six months of age, at least three principal criteria. 2. Meeting Japanese Ministry of Health criteria for coronary aneurysm defined as an internal lumen diameter of \>3 mm in children less than 5 years of age or \>4 mm in children 5 years of age and older, in either the proximal right coronary artery or the proximal left anterior descending coronary artery and at least one principal criterion. AND Enrollment within ten days of the onset of illness, with Day 1 defined as the first day of fever AND Informed consent of parents and assent of children who are older than age 7 years and capable of understanding or according to institutional guidelines.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Pediatric Heart Network: collaborator

Related Publications (4)

• Printz BF, Sleeper LA, Newburger JW, Minich LL, Bradley T, Cohen MS, Frank D, Li JS, Margossian R, Shirali G, Takahashi M, Colan SD; Pediatric Heart Network Investigators. Noncoronary cardiac abnormalities are associated with coronary artery dilation and with laboratory inflammatory markers in acute Kawasaki disease. J Am Coll Cardiol. 2011 Jan 4;57(1):86-92. doi: 10.1016/j.jacc.2010.08.619.

  PMID: 21185506 DERIVED

• Sleeper LA, Minich LL, McCrindle BM, Li JS, Mason W, Colan SD, Atz AM, Printz BF, Baker A, Vetter VL, Newburger JW; Pediatric Heart Network Investigators. Evaluation of Kawasaki disease risk-scoring systems for intravenous immunoglobulin resistance. J Pediatr. 2011 May;158(5):831-835.e3. doi: 10.1016/j.jpeds.2010.10.031. Epub 2010 Dec 18.

  PMID: 21168857 DERIVED

• Baker AL, Lu M, Minich LL, Atz AM, Klein GL, Korsin R, Lambert L, Li JS, Mason W, Radojewski E, Vetter VL, Newburger JW; Pediatric Heart Network Investigators. Associated symptoms in the ten days before diagnosis of Kawasaki disease. J Pediatr. 2009 Apr;154(4):592-595.e2. doi: 10.1016/j.jpeds.2008.10.006. Epub 2008 Nov 28.

  PMID: 19038400 DERIVED

• Newburger JW, Sleeper LA, McCrindle BW, Minich LL, Gersony W, Vetter VL, Atz AM, Li JS, Takahashi M, Baker AL, Colan SD, Mitchell PD, Klein GL, Sundel RP; Pediatric Heart Network Investigators. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease. N Engl J Med. 2007 Feb 15;356(7):663-75. doi: 10.1056/NEJMoa061235.

  PMID: 17301297 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Infections; Coronary Aneurysm

Interventions

Steroids

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Aneurysm; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lynn Sleeper, ScD.

  New England Research Institutes, Watertown, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: December 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: March 4, 2014

Record last verified: 2012-04