Infections Clinical Trial
— SubklasseOfficial title:
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 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.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | AMC | Amsterdam | |
Netherlands | VU | Amsterdam | |
Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | |
Netherlands | UMCG | Groningen | |
Netherlands | LUMC | Leiden | |
Netherlands | AZM | Maastricht | |
Netherlands | UMC St Radboud | Nijmegen | |
Netherlands | Erasmus MC | Rotterdam | |
Netherlands | UMCU | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Sanquin |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 27 months | No | |
Secondary | Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements. | 27 months | Yes |
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