Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 9
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Antibiotics
A: co-trimoxazole prophylactically for 12 months followed by intravenous immunoglobulin treatment for 12 months.
Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given.
干预措施: intravenous immunoglobulins (Drug)
Antibiotics
A: co-trimoxazole prophylactically for 12 months followed by intravenous immunoglobulin treatment for 12 months.
Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given.
干预措施: antibiotics (Drug)
intravenous immunoglobulins
B: intravenous immunoglobulin treatment for 12 months followed by co-trimoxazole prophylactically for 12 months.
Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given.
干预措施: intravenous immunoglobulins (Drug)
intravenous immunoglobulins
B: intravenous immunoglobulin treatment for 12 months followed by co-trimoxazole prophylactically for 12 months.
Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given.
干预措施: antibiotics (Drug)
结局指标
主要结局
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.
时间窗: 27 months
次要结局
- Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements.(27 months)