Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• IgG subclass deficiency and/or (selective) antipolysaccharide antibody deficiency

• At least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients.

• Total serum IgG > 4 g/l

• ≥ 5 years of age

• Informed consent

Exclusion Criteria:

• Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study

• Allergic reactions against human plasma/plasma products, or co-trimoxazole

• An ongoing progressive terminal disease

• Pregnancy or lactation

• History of (transient) cerebrovascular accident or coronary insufficiency

• Renal insufficiency (plasma creatinin > 115 µmol/L; or creatinin clearance <20 ml/min)

• An ongoing active disease causing general symptoms e.g. chronic active hepatitis or persistent enterovirus infection with ongoing systemic complaints

• Detectable anti-IgA antibodies

• Active systemic lupus erythematosus (SLE)

• Glucose-6-phosphate hydrogenase deficiency