Clinical trial NCT00522821: Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response
Official title: Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IgG Deficiency
Infections
Keywords: IgG subclass deficiency
Anti-polysaccharide deficiency
therapy
Immunoglobulins, Intravenous
co-trimoxazole
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
First posted: 2007-08-30
Enrollment: 55
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 description: 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.

Eligibility 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

Primary outcomes:
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.
timeFrame: 27 months
Secondary outcomes:
measure: Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements.
timeFrame: 27 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC
city: Amsterdam
country: Netherlands
facility: VU
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Groningen
country: Netherlands
facility: UMCG
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: AZM
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
affiliation: LUMC
name: J T van Dissel, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AIDS Malignancy Consortium
name: T W Kuijpers, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMCU
name: E AM Sanders, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: