Clinical Trial: Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response

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

Official Title: Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response

Brief Summary: There is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. Therefore, the Dutch Inter University Working Party will start a study in which the treatment with antibiotics is compared with intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.

Detailed Summary:

There is no consensus on the treatment of patients with recurrent infections and isolated IgG-subclass deficiency and/or selective antipolysaccharide antibody deficiency. At present, there are no robust criteria to predict which patient will or will not respond adequately to antibiotic treatment or to IVIG. Furthermore, it is unknown whether IVIG treatment improves the quality of life in these patients. Therefore, the Dutch InterUniversity Working Party intends to start a study in this patient group. In this study, treatment for a year with antibiotics will be compared with a year intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.

The patient will visit the clinic every 3 months during which laboratory tests and physiological measurements will be performed. Moreover the occurrence of infections and fever, the use of antibiotics, hospital admissions, and quality of life will be documented.

The study should result in a national harmonization in the treatment of this patient group. To this end, the results of the study will be used to compile a treatment protocol for this group of patients in the Netherlands and if applicable also in other countries worldwide.

Sponsor: Sanquin

Current Primary Outcome: the number, duration and type of infection (including use of antibiotics to treat infections), days of fever, hospital admissions and, if applicable, days absent from school or work due to infections. [ Time Frame: 27 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements. [ Time Frame: 27 months ]

Original Secondary Outcome: Same as current

Information By: Sanquin

Dates:
Date Received: August 29, 2007
Date Started: November 2007
Date Completion:
Last Updated: April 3, 2015
Last Verified: April 2015