Treatment of Deficient Subclass or Anti-Polysaccharide Antibody Response (Subklasse)

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.

Official Title

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

Conditions

• IgG Deficiency
• Infections

Study Type

Interventional

Study Design

Prevention, Randomised, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

• 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]
  [Designated as safety issue: No]

Secondary Outcome Measures:

• Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements.
  [Time Frame: 27 months]
  [Designated as safety issue: Yes]

Study Start

November 2007

Eligibility & Criteria

• Ages Eligible for Study: 5 Years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

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

Total Enrolment

40

Contact Details

P S Strengers, MD      
p.strengers@sanquin.nl

I Kleine Budde, PhD      
i.kleinebudde@sanquin.nl