Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response

Infections Clinical Trial

— Subklasse  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522821
• Other study ID #: IUWP2005.01
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2007
• Last updated: April 3, 2015
• Start date: November 2007
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Sanquin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• IgG Deficiency
• Infections

Intervention

Drug:
• intravenous immunoglobulins
Adults: 600 mg/kg bodyweight every 3 weeks Children: 800 mg/kg bodyweight every 3 week
• antibiotics
Children =5-12: If well tolerated, 4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily, every day of the week (max160/800mg/day), combined with 5 mg folic acid. Adults and children =12 years or =40 kg: If well tolerated, 160 mg trimethoprim and 800 mg sulfamethoxazole once daily, every day of the week combined with 5 mg folic acid.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanquin

Country where clinical trial is conducted

Netherlands, 

Outcome

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