Treatment of Deficient Subclass or Anti-Polysaccharide Antibody Response

Condition(s) targeted: IgG Deficiency; Infections

Intervention: intravenous immunoglobulins (Drug); co-trimoxazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanquin

Official(s) and/or principal investigator(s):
J T van Dissel, PhD, MD, Principal Investigator, Affiliation: LUMC
T W Kuijpers, PhD, MD, Principal Investigator, Affiliation: AIDS Malignancy Clinical Trials Consortium
E AM Sanders, PhD, MD, Principal Investigator, Affiliation: UMCU

Overall contact:
P S Strengers, MD, Email: p.strengers@sanquin.nl

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.

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

Study design: Prevention, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements.

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.

Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.

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

P S Strengers, MD, Email: p.strengers@sanquin.nl

AZM, Maastricht, Netherlands; Recruiting
J W Cohen Tervaert, PhD, MD
J W Cohen Tervaert, PhD, MD, Principal Investigator

Erasmus MC, Rotterdam, Netherlands; Recruiting
P M van Hagen, PhD, MD
N G Hartwig, PhD, MD
P M van Hagen, PhD, MD, Principal Investigator
N G Hartwig, PhD, MD, Principal Investigator

AMC, Amsterdam, Netherlands; Recruiting
R JM ten Berge, PhD, MD
T W Kuijpers, PhD, MD
R JM ten Berge, PhD, MD, Principal Investigator
T W Kuijpers, PhD, MD, Principal Investigator

LUMC, Leiden, Netherlands; Recruiting
J T van Dissel, PhD, MD
M J Van Tol, PhD, MD
J T van Dissel, PhD,MD, Principal Investigator
M J van Tol, PhD,MD, Principal Investigator
R G Bredius, PhD,MD, Principal Investigator

UMCG, Groningen, Netherlands; Recruiting
C GM Kallenberg, PhD,MD
C GM Kallenberg, PhD,MD, Principal Investigator

UMC St Radboud, Nijmegen, Netherlands; Recruiting
M van Deuren, PhD,MD
A Warris, PhD,MD
M van Deuren, PhD,MD, Principal Investigator
A Warris, PhD,MD, Principal Investigator

UMCU, Utrecht, Netherlands; Recruiting
E AM Sanders, PhD,MD
I M Hoepelman, PhD,MD
E AM Sanders, PhD,MD, Principal Investigator
I M Hoepelman, PhD,MD, Principal Investigator
G Rijkers, PhD, Principal Investigator

VU, Amsterdam, Netherlands; Not yet recruiting
M A van Agtmael, PhD,MD
M van Agtmael, Principal Investigator

Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands; Recruiting
E de Vries, PhD,MD
E de Vries, PhD,MD, Principal Investigator

Starting date: November 2007
Ending date: May 2012
Last updated: April 28, 2009