Clinical Trial: Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea

Brief Summary: Children are at risk of developing an involuntary movement disorder after streptococcal throat infections. Not all children are affected and the severity is individually variable. Affected children have alteration in their behaviour and mood and can become quite compromised in their activities of daily living. The condition is believed to be related to the body having an over efficient immune response to the infection and some of the antibodies made in response to the infection also "attack" centres in the brain controlling movement and mood. Treating these children with immunoglobulins, which "mop up" the antibodies may reverse or improve affected children. This study hopes to clarify this.

Detailed Summary:

INTRODUCTION Acute Rheumatic Fever (ARF), chronic rheumatic heart disease (RHD) and neuropsychiatric/ movement disorders related to group A beta haemolytic streptococcal infections (GABAS) remain major public health problems in South Africa. RHD may require repeated hospital admissions, invasive surgery and often results in premature death. In Africa ARF has a mortality of 2-3%. 1 Likewise, neuropsychiatric disorders such as Sydenham's Chorea (SC) resulting from GABAS result in school difficulties, frequent absenteeism, behaviour problems such as obsessive compulsive disorder and may progress to Tourette Syndrome (personal experience). Patients may suffer from disabling neurologic and psychiatric symptoms many years after their initial episode of ARF (personal experience). The morbidity from these conditions demands enormous resources from the state in terms of medical and surgical treatment and we believe results in preventable stress and suffering to the patient and his or her family. Whilst the ideal goal is primary prevention a measure of secondary prevention has been attained by the use of monthly prophylactic penilente. In cases where ARF has occurred, some further intervention is desirable, to prevent the above complications.

At the Rheumatic Fever Clinic (RFC) at Red Cross Hospital patients with established RHD and old cases of Sydenham's Chorea ( SC) are seen. There are 2-4 new cases of ARF seen per month. ARF remains a notifiable disease but it appears that these new cases are often not notified. (personal communication PAWC health officials) SC is a major manifestation of ARF and following the 1992 update of the modified Jones Criteria, it is sufficient alone to make a diagnosis of ARF.2 The duration of SC ranges from a few weeks to 2 years. Recurrences occur in one third of patients.3 Current treatment of SC is purely symptomatic and whether it resolves in 6 w
Sponsor: University of Cape Town

Current Primary Outcome: improved scores on the sydenham chorea assessment charts [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: improved quality of life [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: University of Cape Town

Dates:
Date Received: February 1, 2008
Date Started: May 2002
Date Completion:
Last Updated: December 3, 2014
Last Verified: December 2014