Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response
5 Years
N/A
Both
IgG Deficiency, Infections
Trial Information
Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
27 months
Safety Issue:
No
Principal Investigator
J T van Dissel, PhD, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
LUMC
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
IUWP2005.01
NCT ID:
NCT00522821
Start Date:
November 2007
Completion Date:
November 2014
Related Keywords:
- IgG Deficiency
- Infections
- IgG subclass deficiency
- Anti-polysaccharide deficiency
- therapy
- Immunoglobulins, Intravenous
- co-trimoxazole
- IgG Deficiency
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