drugset / Trial / NCT00522821

Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response

NCT00522821

Phase 4 Completed 55 enrolled Prothya Biosolutions
RandomizedCrossoverOpen-labelPrevention

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.

Timeline

Start
2007-11
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 600 mg/kg Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 800 mg/kg Intravenous
Subject Sulfamethoxazole Small molecule 20 mg/kg
Subject Sulfamethoxazole Small molecule 800 mg
Subject Trimethoprim Small molecule 4 mg/kg
Subject Trimethoprim Small molecule 160 mg
Subject azitromycine Unknown
Background folic acid Other / unclassified 5 mg